Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000601538
Ethics application status
Not yet submitted
Date submitted
27/05/2015
Date registered
9/06/2015
Date last updated
15/11/2019
Date data sharing statement initially provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AD-6626 in Normal, Healthy Volunteers
Scientific title
A Single-Center, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of AD 6626 Administered Orally to Normal, Healthy Volunteers
Secondary ID [1] 286818 0
Nil
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 295190 0
Condition category
Condition code
Blood 295440 295440 0 0
Haematological diseases
Human Genetics and Inherited Disorders 295487 295487 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of sequential dose escalation with approximately 3 cohorts of subjects (8 subjects per cohort) given oral doses of AD-6626 or placebo given twice daily for 10 days. The doses of AD-6626 are 150mg, 300mg, and 600mg. The AD-6626 is dissolved in cranberry juice for administration
Intervention code [1] 291976 0
Treatment: Drugs
Comparator / control treatment
Placebo which is cranberry juice delivered as an oral solution
Control group
Placebo

Outcomes
Primary outcome [1] 295174 0
Frequencies and types of AEs and SAEs through physical examination including vital signs, ECGs, pulse oximetry and safety laboratory tests
Timepoint [1] 295174 0
From the time of signed consent through the end of study date which occurs on Day 16
Secondary outcome [1] 314943 0
Pharmacokinetics of AD-6626 and its active metabolite as assessed through blood collection during the study
Timepoint [1] 314943 0
PK samples at the following timepoints
Day 0: within 5 minutes before Dose #1 and post Dose #1 at 15, 30, 45, 60, and 90 minutes and at 2, 3, 4, 6, 8, and 12 hours (before Dose #2).
- Days 1, 2, 3, 4, 5, and 7 (trough): within 5 minutes before the first dose each day.
- Day 9: within 5 minutes before Dose #19 and post Dose #19 at 15, 30, 45, 60, and 90 minutes and at 2,
3, 4, 6, 8, and 12 hours (before Dose #20).
- Day 10: at 12 and 24 hours post Dose #20.
- Day 11: at 36 and 48 hours post Dose #20.
- Day 12: at 72 hours post Dose #20.
- Day 16.

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.
Minimum age
21 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
23/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291359 0
Commercial sector/Industry
Name [1] 291359 0
Aldea Pharmaceuticals
Country [1] 291359 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Aldea Pharmaceuticals
Address
3696 Haven Avenue, Suite C Redwood City, CA 94063
Country
United States of America
Secondary sponsor category [1] 290039 0
None
Name [1] 290039 0
Address [1] 290039 0
Country [1] 290039 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292920 0
Alfred Research & Ethics Committee
Ethics committee address [1] 292920 0
Ethics committee country [1] 292920 0
Australia
Date submitted for ethics approval [1] 292920 0
28/04/2015
Approval date [1] 292920 0
Ethics approval number [1] 292920 0

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

Contacts
Principal investigator
Name 57630 0
Dr Jason Lickliter, MBBS PhD FRACP
Address 57630 0
Nucleus Network Limited Level 5 Burnet Institute AMREP Precinct 89 Commercial Road Melbourne Victoria 3004
Country 57630 0
Australia
Phone 57630 0
+61 3 9076 8960
Fax 57630 0
Email 57630 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 57631 0
Jason Lickliter, MBBS PhD FRACP
Address 57631 0
Nucleus Network Limited Level 5 Burnet Institute AMREP Precinct 89 Commercial Road Melbourne Victoria 3004
Country 57631 0
Australia
Phone 57631 0
+61 3 9076 8960
Fax 57631 0
Email 57631 0
j.lickliter@nucleusnetwork.com.au
Contact person for scientific queries
Name 57632 0
Richard Shames
Address 57632 0
ALDEA Pharmaceuticals 3696 Haven Avenue, Suite C Redwood City, CA 94063
Country 57632 0
United States of America
Phone 57632 0
+1 650-575-0798
Fax 57632 0
Email 57632 0
rshames@aldeapharma.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study canceled


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.