Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000272998
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
2/03/2020
Date last updated
13/07/2021
Date data sharing statement initially provided
2/03/2020
Date results information initially provided
13/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing how fast the trial drug GS-6207 is processed and cleared from the body, in healthy adults and in adults with severely reduced kidney function.
Scientific title
A Phase 1 Open-Label, Parallel-Design, Single-Dose Study to Evaluate the Pharmacokinetics of GS-6207 in Participants with Normal Renal Function and Severe Renal Impairment
Secondary ID [1] 300607 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 316362 0
Condition category
Condition code
Infection 314626 314626 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test an experimental drug named GS-6207, which has been developed for the treatment of HIV infection.

- the dose administered, 300 mg
- the duration of administration, once
- the mode of administration, oral tablet
Intervention code [1] 316919 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322955 0
The purpose of this study is to:
• Measure the amount of GS-6207 in participants with normal or severely impaired renal (kidney) function that gets into the blood stream and how long it takes to get rid of it.
Timepoint [1] 322955 0
Blood draws will occur at the following time points:
Days 1, 2, 4, 6, 8, 15, 22, 29, 36, 43, 50
Secondary outcome [1] 380359 0
To evaluate the safety and tolerability of GS-6207 single dose administration in participants with normal or severely impaired renal function. This is assessed by adverse event capture and physical examinations as required.
Timepoint [1] 380359 0
A symptom driven physical assesment and adverse event collection will occur at the following time-points:
Days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50

Eligibility
Key inclusion criteria
Be aged 18 through 79 years of age, inclusive, at screening

Have a calculated BMI of (± 20%) 18 > BMI < 40 kg/m2 at screening

Participants have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from study center admission, throughout the study period, and continuing for at least 60 days following the last dose of study drug
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any prior exposure to GS-6207, unless allowed by the sponsor

Have current alcohol or substance abuse judged by the investigator to potentially interfere
with participant compliance or participant safety, or a positive drug or alcohol test at
screening or baseline

Have a positive test result for HIV-1/2 antibody, hepatitis B surface antigen, or hepatitis C
virus antibody at screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Date of first participant enrolment
Anticipated
1/04/2020
Actual
15/06/2020
Date of last participant enrolment
Anticipated
Actual
5/11/2020
Date of last data collection
Anticipated
Actual
1/02/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 22367 0
New Zealand
State/province [1] 22367 0
Country [2] 22368 0
Canada
State/province [2] 22368 0
Country [3] 22369 0
United States of America
State/province [3] 22369 0

Funding & Sponsors
Funding source category [1] 305027 0
Commercial sector/Industry
Name [1] 305027 0
Gilead Sciences
Country [1] 305027 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Gilead Sciences, Inc.
333 Lakeside Drive, Foster City, CA 94404, USA
Country
United States of America
Secondary sponsor category [1] 305388 0
None
Name [1] 305388 0
Address [1] 305388 0
Country [1] 305388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305423 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 305423 0
201 Great King Street, Dunedin 9016, New Zealand
Ethics committee country [1] 305423 0
New Zealand
Date submitted for ethics approval [1] 305423 0
28/02/2020
Approval date [1] 305423 0
01/04/2020
Ethics approval number [1] 305423 0
20/STH/40

Summary
Brief summary
Medicines are cleared from the body in different ways. Some medicines are mainly cleared from the body by the kidneys. When the kidneys work less well, they are no longer able to clear those medicines as fast. This can lead to a build-up of medicine in the body, unless smaller or less frequent doses are used.

Research suggests the kidneys are not very important in clearing GS-6207 from the body. The study team wants to confirm this by giving a single dose of GS-6207 to two groups of participants: adults with normal kidney function; and adults with severely reduced kidney function. The amount of GS-6207 in blood and urine after dosing will be measured, and the results of the two groups will then be compared.

The study will also collect information about how safe and well-tolerated GS-6207 is in adults with normal and severely reduced kidney function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100330 0
Dr Richard Robson
Address 100330 0
Christchurch Clinical Studies Trust Ltd

Level 4, 264 Antigua Street, Christchurch 8011, NZ
Country 100330 0
New Zealand
Phone 100330 0
+64 33729477
Fax 100330 0
Email 100330 0
Richard@ccst.co.nz
Contact person for public queries
Name 100331 0
Mr Sean Connell
Address 100331 0
Gilead Sciences Australia
417 St Kilda Road Melbourne Vic 3004
Country 100331 0
Australia
Phone 100331 0
+61 3 92724454
Fax 100331 0
Email 100331 0
sean.connell1@gilead.com
Contact person for scientific queries
Name 100332 0
Mr Sean Connell
Address 100332 0
Gilead Sciences Australia
417 St Kilda Road Melbourne Vic 3004
Country 100332 0
Australia
Phone 100332 0
+61 3 92724454
Fax 100332 0
Email 100332 0
sean.connell1@gilead.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be used in part of a regulatory submission.


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.