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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/NCT02616445
Registration number
NCT02616445
Ethics application status
Date submitted
5/11/2015
Date registered
30/11/2015
Date last updated
2/05/2017
Titles & IDs
Public title
Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects
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Scientific title
A Phase I Double-Blind, Randomised, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UE2343 in Healthy Subjects
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Secondary ID [1]
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ACW0001
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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 - UE2343
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - UE2343
Treatment: Drugs - UE2343
Placebo Comparator: MAD Study -
Placebo Comparator: Fed-Fasted -
Experimental: CSF -
Treatment: Drugs: UE2343
UE2343
10mg, 20, 35mg
twice daily for 9 days
Treatment: Drugs: Placebo
10mg, 20, 35mg
twice daily for 9 days
Treatment: Drugs: Placebo
Cross-over study
single dose administered twice (on day 1 and day 8)
study duration 17 days
Treatment: Drugs: UE2343
Cross-over study
UE2343
single dose administered twice (on day 1 and day 8)
study duration 17 days
Treatment: Drugs: UE2343
UE2343
twice daily for 3 days
single dose on day 4
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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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Assess Safety and Tolerability of UE2343 over 17 days including AEs, 12-lead ECGs, vital signs, Nerve conduction velocity, Labs.
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Assessment method [1]
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Timepoint [1]
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Up to Day 17
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Primary outcome [2]
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Assess the Pharmacokinetic (PK) Plasma Parameter Maximum Plasma Concentration (Cmax) of UE2343 after a single dose
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Assessment method [2]
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Timepoint [2]
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Day 1 and Day 8
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Primary outcome [3]
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Assess the Pharmacokinetic (PK) Plasma Parameter Time to Cmax (Tmax) of UE2343 after a single dose
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Assessment method [3]
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Timepoint [3]
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Day 1 and Day 8
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Primary outcome [4]
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Assess the Pharmacokinetic (PK) Plasma Parameter Area Under the Curve (AUC) of UE2343 after a single dose
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Assessment method [4]
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Timepoint [4]
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Day 1 and Day 8
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Primary outcome [5]
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Assess the Pharmacokinetic (PK) Plasma Parameter Terminal Elimination Half Life (t½) of UE2343 after a single dose
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Assessment method [5]
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Timepoint [5]
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Day 1 and Day 8
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Primary outcome [6]
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Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF
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Assessment method [6]
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Timepoint [6]
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Day 4
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Secondary outcome [1]
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Assess Pharmacokinetics (PK) Plasma parameter Maximum Plasma Concentration (Cmax) from time of dosing to 12 hours
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Assessment method [1]
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Timepoint [1]
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Day 1 and Day 10
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Secondary outcome [2]
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Assess Pharmacokinetics (PK) Plasma parameter Time to Cmax (Tmax) from time of dosing to 12 hours
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Assessment method [2]
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Timepoint [2]
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Day 1 and Day 10
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Secondary outcome [3]
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Assess Pharmacokinetics (PK) Plasma parameter Area Under the Curve (AUC) from time of dosing to 12 hours
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Assessment method [3]
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0
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Timepoint [3]
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Day 1 and Day 10
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Secondary outcome [4]
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Assess Pharmacokinetics (PK) Plasma parameter Terminal Elimination Half Life (t½) from time of dosing to 12 hours
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Assessment method [4]
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Timepoint [4]
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Day 1 and Day 10
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Secondary outcome [5]
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Assess Pharmacokinetics (PK) Urine parameters (Amount of drug excreted in urine (Ae) and Ae as a % of dose) from time of dosing to 24 hours
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Assessment method [5]
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Timepoint [5]
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Day 1 and Day 10
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Secondary outcome [6]
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Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF compared to the Cmax value obtained in plasma
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Assessment method [6]
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Timepoint [6]
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Day 4
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Secondary outcome [7]
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Assess Pharmacodynamics (PD) Blood parameter Adrenocorticotropic hormone (ACTH) from baseline to end of study
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Assessment method [7]
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0
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Timepoint [7]
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Days 1, 10, 11, 12, 13 and 17.
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Secondary outcome [8]
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Assess Pharmacodynamics (PD) Blood parameter Serum Cortisol from baseline to end of study
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Assessment method [8]
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0
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Timepoint [8]
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Days 1, 10, 11, 12, 13 and 17.
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Secondary outcome [9]
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Assess Pharmacodynamics (PD) Blood parameter for Adrenal Androgens from baseline to end of study
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Assessment method [9]
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0
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Timepoint [9]
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Days 1, 10, 11, 12, 13 and 17.
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Secondary outcome [10]
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Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisol (UFF) from baseline to end of study
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Assessment method [10]
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Timepoint [10]
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Days 1, 10, 11 and 12
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Secondary outcome [11]
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Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisone (UFE) from baseline to end of study
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Assessment method [11]
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Timepoint [11]
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Days 1, 10, 11 and 12
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Secondary outcome [12]
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Assess Pharmacodynamics (PD) Urine parameter 5a-tetrahydrocortisol (5aTHF) from baseline to end of study
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Assessment method [12]
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Timepoint [12]
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Days 1, 10, 11 and 12
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Secondary outcome [13]
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Assess Pharmacodynamics (PD) Urine parameter 5ß-tetrahydrocortisol (5ßTHF) from baseline to end of study
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Assessment method [13]
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Timepoint [13]
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Days 1, 10, 11 and 12
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Secondary outcome [14]
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Assess Pharmacodynamics (PD) Urine parameter tetrahydrocortisone (THE) from baseline to end of study
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Assessment method [14]
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Timepoint [14]
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Days 1, 10, 11 and 12
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Eligibility
Key inclusion criteria
- Willing to use specified contraception
- BMI within specified range
- No clinically significant abnormalities in the results of laboratory evaluations at
Screening and Day -1.
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Minimum age
18
Years
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Maximum age
65
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
- Abnormal medical history, including history of dementia
- No significant allergic reactions
- No prior drug or alcohol abuse
- Use of regular prescribed medication
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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
Factorial
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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
1/02/2015
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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
1/09/2015
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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)
WA
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Recruitment hospital [1]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Actinogen Medical
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Address
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Country
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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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Novotech (Australia) Pty Limited
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Linear Clinical Research
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether the drug UE2343, a potential treatment for
Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics
and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study
will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02616445
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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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Vincent Ruffles
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Address
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Actinogen Medical
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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/NCT02616445
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