Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000056594
Ethics application status
Approved
Date submitted
30/12/2014
Date registered
22/01/2015
Date last updated
22/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AD-6626 in Normal, Healthy Volunteers and Subjects Heterozygous for the Aldehyde Dehydrogenase 2*1/*2 Genetic Variant With and Without Alcohol Administration
Scientific title
A Single-Center, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Single-dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of a Single Dose of AD-6626 Administered Orally to Normal, Healthy Volunteers in Part A and the Safety/Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of a Single Oral Dose of AD-6626 Followed by Alcohol Administration in Normal, Healthy Volunteers With the Aldehyde Dehydrogenase 2 (ALDH2)*1/*1 (Wild Type) or ALDH2*1/*2 (Heterozygous) Genetic Variant in Part B
Secondary ID [1] 285896 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study is for healthy volunteers. The intended use of the investigational product is the treatment of Fanconi Anemia 293819 0
Condition category
Condition code
Human Genetics and Inherited Disorders 294122 294122 0 0
Other human genetics and inherited disorders
Blood 294240 294240 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A consists of sequential dose escalation with approximately 5 cohorts of subjects (8 subjects per cohort) given a single oral dose of AD-6626 or placebo. The doses of AD-6626 are 100mg, 300mg, 600mg, 1200mg and 1200mg with food.
Part B is a two period crossover of single oral administration of AD-6626 or placebo following oral EtOH administration in NHVs or subjects with the ALDH2*1/*2 (HeZ) genotype. A total of 24 subjects will be dosed. The dose of AD-6626 will be determined from Part A of the study. The oral EtOH dose will be 0.75 gm/kg for NHVs and 0.5 gm/kg for subjects with the ALDH2*1/*2 genotype. The AD-6626 will be given 30 minutes before the oral dose of EtOH. There will be 7 days between the treatments in Part B
Intervention code [1] 290878 0
Treatment: Drugs
Comparator / control treatment
Placebo which is cranberry juice delivered as an oral solution
Control group
Placebo

Outcomes
Primary outcome [1] 293924 0
Frequencies and types of AEs and SAEs through physical examination including vital signs, ECGs, pulse oximetry and safety laboratory tests
Timepoint [1] 293924 0
From the time of signed consent through the end of study date which occurs on Day 7 for Part A and Day 7 of Period 2 for Part B of the study
Secondary outcome [1] 312155 0
Pharmacokinetics of AD-6626 and its active metabolite as assessed through blood collection during the study
Timepoint [1] 312155 0
For both Part A and Part B, PK samples within 60 minutes before dosing and postdose at 15, 30, 45, 60, 90, 120, 180, 240, and 300 minutes, and 8 and 12 hours (Day 0); 24 and 36 hours (Day 1); 48 and 60 hours (Day 2); 72 hours (Day 3); and on Day 7 (EOS).

Eligibility
Key inclusion criteria
This study will be conducted in normal, healthy, adult, male or female aged between 21-45 years and with a BMI greater than or equal to 18 and less than or equal to 30. Eligible subjects will be in good health without signs or symptoms of current illness and with predose clinical and laboratory examinations without clinically significant findings. Subjects in Part A will be of non-Asian descent. Subjects in Part B will be of Asian or non-Asian descent with ALDH2*1/*2 (HeZ) or ALDH2*1/*1 (WT) genotype, respectively
Minimum age
21 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Homozygous for the ALDH2*2/*2 genotype
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of severe allergic or anaphylactic reactions
- Fever (body temperature >38 degrees celsius) or symptomatic viral or bacterial infection within 2 weeks prior to Screening
- Blood pressure (BP) >140/90 mm Hg or a heart rate (HR) >100 beats per minute at Screening and at Day -1
- Clinically significant laboratory abnormalities
- Female who is breastfeeding or has a positive pregnancy test at any visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/01/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290481 0
Commercial sector/Industry
Name [1] 290481 0
Aldea Pharmaceuticals
Country [1] 290481 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nucleus Network
Address
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne
Victoria, 3004
Country
Australia
Secondary sponsor category [1] 289184 0
Commercial sector/Industry
Name [1] 289184 0
Aldea Pharmaceuticals
Address [1] 289184 0
3696 Haven Avenue, Suite C
Redwood City, CA 94063
Country [1] 289184 0
United States of America

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53734 0
Dr Jason Lickliter, MBBS PhD FRACP
Address 53734 0
Nucleus Network Limited Level 5 Burnet Institute AMREP Precinct 89 Commercial Road Melbourne Victoria 3004
Country 53734 0
Australia
Phone 53734 0
+61 3 9076 8960
Fax 53734 0
Email 53734 0
[email protected]
Contact person for public queries
Name 53735 0
Jason Lickliter, MBBS PhD FRACP
Address 53735 0
Nucleus Network Limited Level 5 Burnet Institute AMREP Precinct 89 Commercial Road Melbourne Victoria 3004
Country 53735 0
Australia
Phone 53735 0
+61 3 9076 8960
Fax 53735 0
Email 53735 0
[email protected]
Contact person for scientific queries
Name 53736 0
Richard Shames
Address 53736 0
ALDEA Pharmaceuticals 3696 Haven Avenue, Suite C Redwood City, CA 94063
Country 53736 0
United States of America
Phone 53736 0
+1 650-575-0798
Fax 53736 0
Email 53736 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.