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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03163550
Registration number
NCT03163550
Ethics application status
Date submitted
15/05/2017
Date registered
23/05/2017
Date last updated
2/12/2017
Titles & IDs
Public title
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
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Scientific title
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and the Drug-Drug Interaction Potential of Oral ACHN-383 and ACHN-789 in Healthy Subjects
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Secondary ID [1]
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ACHN-172-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ACHN-383
Treatment: Drugs - ACHN-789
Treatment: Drugs - Placebo
Experimental: Cohort 1 - Healthy volunteers
Experimental: Cohort 2 - Healthy volunteers
Experimental: Cohort 3 - Healthy volunteers
Experimental: Cohort 4 - Healthy volunteers
Experimental: Cohort 5 - Healthy volunteers
Treatment: Drugs: ACHN-383
Oral dose
Treatment: Drugs: ACHN-789
Oral dose
Treatment: Drugs: Placebo
Oral dose
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
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Assessment method [1]
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0
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Timepoint [1]
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26 days
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Primary outcome [2]
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Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
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Assessment method [2]
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0
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Timepoint [2]
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26 days
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Primary outcome [3]
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Incidence and severity of adverse events
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Assessment method [3]
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0
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Timepoint [3]
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26 days
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Primary outcome [4]
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Changes from baseline in the QTcF interval
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Assessment method [4]
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0
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Timepoint [4]
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19 days
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Secondary outcome [1]
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PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
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Assessment method [1]
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0
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Timepoint [1]
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1 day
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Secondary outcome [2]
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PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
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Assessment method [2]
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0
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Timepoint [2]
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3 days
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Secondary outcome [3]
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PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
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Assessment method [3]
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0
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Timepoint [3]
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1 day
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Secondary outcome [4]
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PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
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Assessment method [4]
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0
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Timepoint [4]
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3 days
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Secondary outcome [5]
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PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
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Assessment method [5]
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0
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Timepoint [5]
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1 day
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Secondary outcome [6]
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PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
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Assessment method [6]
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0
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Timepoint [6]
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3 days
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Secondary outcome [7]
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PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
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Assessment method [7]
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0
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Timepoint [7]
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1 day
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Secondary outcome [8]
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PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
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Assessment method [8]
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0
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Timepoint [8]
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3 days
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Secondary outcome [9]
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PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
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Assessment method [9]
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0
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Timepoint [9]
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1 day
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Secondary outcome [10]
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PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
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Assessment method [10]
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0
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Timepoint [10]
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3 days
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Secondary outcome [11]
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PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
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Assessment method [11]
0
0
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Timepoint [11]
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0
1 day
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Secondary outcome [12]
0
0
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
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Assessment method [12]
0
0
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Timepoint [12]
0
0
3 days
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Secondary outcome [13]
0
0
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
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Assessment method [13]
0
0
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Timepoint [13]
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0
1 day
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Secondary outcome [14]
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0
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
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Assessment method [14]
0
0
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Timepoint [14]
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0
3 days
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Secondary outcome [15]
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0
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
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Assessment method [15]
0
0
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Timepoint [15]
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0
1 day
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Secondary outcome [16]
0
0
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
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Assessment method [16]
0
0
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Timepoint [16]
0
0
3 days
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Secondary outcome [17]
0
0
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [17]
0
0
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Timepoint [17]
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0
1 day
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Secondary outcome [18]
0
0
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [18]
0
0
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Timepoint [18]
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0
5 days
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Secondary outcome [19]
0
0
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [19]
0
0
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Timepoint [19]
0
0
1 day
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Secondary outcome [20]
0
0
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [20]
0
0
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Timepoint [20]
0
0
5 days
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Secondary outcome [21]
0
0
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [21]
0
0
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Timepoint [21]
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0
1 day
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Secondary outcome [22]
0
0
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [22]
0
0
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Timepoint [22]
0
0
5 days
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Secondary outcome [23]
0
0
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [23]
0
0
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Timepoint [23]
0
0
1 day
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Secondary outcome [24]
0
0
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [24]
0
0
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Timepoint [24]
0
0
5 days
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Secondary outcome [25]
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0
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [25]
0
0
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Timepoint [25]
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0
1 day
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Secondary outcome [26]
0
0
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [26]
0
0
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Timepoint [26]
0
0
5 days
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Secondary outcome [27]
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0
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [27]
0
0
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Timepoint [27]
0
0
1 day
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Secondary outcome [28]
0
0
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [28]
0
0
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Timepoint [28]
0
0
5 days
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Secondary outcome [29]
0
0
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [29]
0
0
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Timepoint [29]
0
0
1 day
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Secondary outcome [30]
0
0
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [30]
0
0
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Timepoint [30]
0
0
5 days
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Secondary outcome [31]
0
0
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [31]
0
0
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Timepoint [31]
0
0
1 day
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Secondary outcome [32]
0
0
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [32]
0
0
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Timepoint [32]
0
0
5 days
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Secondary outcome [33]
0
0
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [33]
0
0
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Timepoint [33]
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6 days
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Secondary outcome [34]
0
0
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [34]
0
0
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Timepoint [34]
0
0
6 days
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Secondary outcome [35]
0
0
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [35]
0
0
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Timepoint [35]
0
0
6 days
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Secondary outcome [36]
0
0
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [36]
0
0
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Timepoint [36]
0
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6 days
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Secondary outcome [37]
0
0
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [37]
0
0
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Timepoint [37]
0
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6 days
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Secondary outcome [38]
0
0
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [38]
0
0
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Timepoint [38]
0
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6 days
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Secondary outcome [39]
0
0
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [39]
0
0
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Timepoint [39]
0
0
6 days
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Secondary outcome [40]
0
0
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
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Assessment method [40]
0
0
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Timepoint [40]
0
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6 days
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Secondary outcome [41]
0
0
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [41]
0
0
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Timepoint [41]
0
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19 days
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Secondary outcome [42]
0
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PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [42]
0
0
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Timepoint [42]
0
0
19 days
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Secondary outcome [43]
0
0
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [43]
0
0
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Timepoint [43]
0
0
19 days
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Secondary outcome [44]
0
0
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [44]
0
0
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Timepoint [44]
0
0
19 days
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Secondary outcome [45]
0
0
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [45]
0
0
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Timepoint [45]
0
0
19 days
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Secondary outcome [46]
0
0
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [46]
0
0
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Timepoint [46]
0
0
19 days
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Secondary outcome [47]
0
0
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [47]
0
0
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Timepoint [47]
0
0
19 days
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Secondary outcome [48]
0
0
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
19 days
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Secondary outcome [49]
0
0
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
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Assessment method [49]
0
0
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Timepoint [49]
0
0
19 days
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Secondary outcome [50]
0
0
Urine concentrations of ACHN-789 after single dose administration
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Assessment method [50]
0
0
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Timepoint [50]
0
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1 day
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Secondary outcome [51]
0
0
Urine concentrations of ACHN-383 after single-dose administration
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Assessment method [51]
0
0
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Timepoint [51]
0
0
3 days
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Secondary outcome [52]
0
0
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
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Assessment method [52]
0
0
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Timepoint [52]
0
0
1 day
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Secondary outcome [53]
0
0
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
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Assessment method [53]
0
0
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Timepoint [53]
0
0
5 days
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Secondary outcome [54]
0
0
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
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Assessment method [54]
0
0
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Timepoint [54]
0
0
19 days
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Eligibility
Key inclusion criteria
Key
- Females of child-bearing potential must not be breast feeding, must have a negative
serum pregnancy test, and must use a highly effective method of contraception or be
abstinent from sexual activity prior to the first dose of study, during the study and
for a specified period following the last dose of study drug
- Males must be willing to use a condom for the duration of the study and for a
specified period following the study, unless surgically sterile. In addition, their
female partner must use a highly effective method of contraception, for the same
period of time, unless surgically sterile
- Body mass index (BMI) of =19 kg/m^2 to =32 kg/m^2 and weight =50 kg to =125 kg
- Normal renal function as determined by creatinine clearance (CLcr) rate
Key
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Pregnant women
- History of any hepatic or biliary disorder or disease
- Any condition that could possibly affect oral drug absorption
- Unstable cardiovascular disease
- Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
- HIV positive
- Active malignancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/10/2017
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Clinical Site - Perth
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Recruitment postcode(s) [1]
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- Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Achaogen, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group
study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug
interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in
healthy subjects
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03163550
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Daniel J Cloutier, PharmD
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Address
0
0
Achaogen, Inc.
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03163550
Download to PDF