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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/NCT04889690
Registration number
NCT04889690
Ethics application status
Date submitted
12/05/2021
Date registered
17/05/2021
Date last updated
17/05/2021
Titles & IDs
Public title
Study of Multiple Doses of Danicopan in Healthy Participants
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Scientific title
A Multiple Ascending Dose Study To Assess Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ACH-0144471 In Healthy Volunteers
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Secondary ID [1]
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ACH471-002
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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
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Danicopan
Treatment: Drugs - Placebo
Experimental: Cohort 1: 200 mg - All participants under fasted conditions received 200 mg of danicopan or placebo twice daily (BID) over a 14-day period.
Experimental: Cohort 2: 500 mg - All participants under fasted conditions received 500 mg of danicopan or placebo BID over a 14-day period.
Experimental: Cohort 3: 800 mg - All participants under fasted conditions received 800 mg of danicopan or placebo BID over a 14-day period.
Experimental: Cohort 4: 75 mg - All participants under fasted conditions received 75 mg of danicopan or placebo thrice daily (TID) over a 7-day period.
Treatment: Drugs: Danicopan
Treatment: Drugs: Placebo
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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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Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities
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Assessment method [1]
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Timepoint [1]
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Day 1 through Day 42
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Secondary outcome [1]
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Maximum Observed Plasma Concentration (Cmax) Of Danicopan
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Assessment method [1]
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Timepoint [1]
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Up to 16 hours postdose
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Secondary outcome [2]
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Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan
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Assessment method [2]
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Timepoint [2]
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Up to 16 hours postdose
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Secondary outcome [3]
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Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Danicopan
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Assessment method [3]
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Timepoint [3]
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Up to 16 hours postdose
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Secondary outcome [4]
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Activity Of Danicopan As Measured By Alternative Pathway (AP) Wieslab Assay
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Assessment method [4]
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Timepoint [4]
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Up to 16 hours postdose
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Secondary outcome [5]
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Relationship Between AP Inhibition And Danicopan Plasma Concentrations
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Assessment method [5]
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Timepoint [5]
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Up to 16 hours postdose
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Eligibility
Key inclusion criteria
- Healthy was defined as having no clinically relevant abnormalities identified by a
detailed medical history, physical exam, blood pressure and heart rate measurements,
12-lead electrocardiogram, and clinical laboratory tests.
- Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of
50 kg.
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Minimum age
25
Years
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Maximum age
55
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
- History or clinically relevant evidence of significant cardiovascular, pulmonary,
hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic,
neurological, or psychiatric disease.
- Any condition possibly affecting drug absorption (including gastrectomy and
cholecystectomy).
- Body temperature greater than or equal to 38°Celcius on Day -1 or Day 1, Hour 0;
history of febrile illness or other evidence of infection within 14 days prior to
first study drug administration.
- Current tobacco/nicotine user; consumption of any alcohol within 72 hours before first
study drug administration or have a history of regular alcohol consumption exceeding
21 drinks/week within 6 months of screening; positive urine drug screen at screening
or Day -1.
- Clinically significant laboratory abnormalities at either Screening or Day -1.
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Study design
Purpose of the study
Basic Science
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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
21/05/2016
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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
11/01/2017
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alexion Pharmaceuticals, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Achillion, a wholly owned subsidiary of Alexion
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This was a multiple ascending dose, randomized, double-blind study assessing the safety,
tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants.
Four different doses (75 milligrams [mg], 200 mg, 500 mg, 800 mg) and dose-matched placebo
were administered under fasted conditions.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04889690
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04889690
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