Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001333606
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
18/12/2014
Date last updated
18/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of 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, Pharmacokinetics, and Pharmacodynamics of a Single Dose of AD-6626 Administered Intravenously to Normal, Healthy Volunteers (NHVs) Without Alcohol Administration in Part A and to NHVs and Subjects Heterozygous for the Aldehyde Dehydrogenase 2*1/*2 Genetic Variant With Alcohol Administration in Part B
Secondary ID [1] 285824 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 acute alcohol intoxication 293739 0
Condition category
Condition code
Other 294039 294039 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A consists of sequential dose escalation with approximately 3 cohorts of subjects (8 subjects per cohort) given an intravenous dose of AD-6626 or placebo and 12 additional subjects given the dose of AD-6626 below the MTD. The doses of AD-6626 are 100mg, 300mg and 750mg.
Part B consists of single intravenous administration of AD-6626 or placebo following oral EtOH administration in NHVs or subjects with the ALDH2*1/*2 (HeZ) genotype. The dose of AD-6626 will be determined from Part A of the study. The oral EtOH dose will be 0.75 gm/kg or 0.5 gm/kg. The AD-6626 will be given 10 minutes after the oral dose of EtOH. Part B will include a cohort of NHVs from Part A who will receive either AD-6626 or placebo according to their Part A treatment assignments.
Intervention code [1] 290802 0
Treatment: Drugs
Comparator / control treatment
Placebo which is 5% Dextrose (Glucose) for Injection
Control group
Placebo

Outcomes
Primary outcome [1] 293816 0
Frequencies and types of AEs and SAEs through physical examination including vital signs, ECGs, pulse oximetry and safety laboratory tests
Timepoint [1] 293816 0
From the time of signed consent through the end of study date which occurs on Day 7 for both Part A and Part B of the study
Secondary outcome [1] 311926 0
Pharmacokinetics of AD-6626 and its active metabolite as assessed through blood collection during the study
Timepoint [1] 311926 0
For both Part A and Part B, PK samples within 60 minutes before start of study drug infusion and post start of study drug infusion 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

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 Cohort 2 will be of Asian descent with the ALDH2*1/*2 (HeZ) genotype
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/12/2014
Actual
18/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290385 0
Commercial sector/Industry
Name [1] 290385 0
Aldea Pharmaceuticals
Country [1] 290385 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Aldea Pharmaceuticals
Address
3696 Haven Ave, Suite C
Redwood City, CA 94063
Country
United States of America
Secondary sponsor category [1] 289112 0
None
Name [1] 289112 0
Address [1] 289112 0
Country [1] 289112 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of AD-6626 without and without alcohol administration in normal healthy volunteers and subjects heterozygous (HeZ) for the aldehyde dehydrogenase 2 (ALDH2)*1/*2 genetic variant
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53434 0
Dr Jason Lickliter, MBBS PhD FRACP
Address 53434 0
Nucleus Network Limited
Level 5 Burnet Institute
AMREP Precinct
89 Commercial Road
Melbourne Victoria 3004
Country 53434 0
Australia
Phone 53434 0
+61 3 9076 8960
Fax 53434 0
Email 53434 0
[email protected]
Contact person for public queries
Name 53435 0
Dr Jason Lickliter, MBBS PhD FRACP
Address 53435 0
Nucleus Network Limited
Level 5 Burnet Institute
AMREP Precinct
89 Commercial Road
Melbourne Victoria 3004
Country 53435 0
Australia
Phone 53435 0
+61 3 9076 8960
Fax 53435 0
Email 53435 0
[email protected]
Contact person for scientific queries
Name 53436 0
Dr Richard Shames
Address 53436 0
ALDEA Pharmaceuticals
3696 Haven Avenue, Suite C
Redwood City, CA 94063
Country 53436 0
United States of America
Phone 53436 0
+1 650-575-0798
Fax 53436 0
Email 53436 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.