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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02400307




Registration number
NCT02400307
Ethics application status
Date submitted
17/03/2015
Date registered
27/03/2015
Date last updated
11/10/2019

Titles & IDs
Public title
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
Scientific title
A Phase 1, Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of GS-9883 in Subjects With Normal and Impaired Renal Function
Secondary ID [1] 0 0
2015-000898-12
Secondary ID [2] 0 0
GS-US-141-1479
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bictegravir

Experimental: Severe Renal Impairment - Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir.

Experimental: Moderate Renal Impairment - Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir.

Experimental: Mild Renal Impairment - Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir.


Treatment: Drugs: Bictegravir
75 mg tablet administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total) - AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Timepoint [1] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary outcome [2] 0 0
PK Parameter: AUCinf of Bictegravir (Free) - Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).
Timepoint [2] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary outcome [3] 0 0
PK Parameter: AUClast of Bictegravir (Total) - AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
Timepoint [3] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary outcome [4] 0 0
PK Parameter: AUClast of Bictegravir (Free) - Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).
Timepoint [4] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary outcome [5] 0 0
PK Parameter: Cmax of Bictegravir (Total) - Cmax is defined as the maximum observed plasma concentration of drug.
Timepoint [5] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary outcome [6] 0 0
PK Parameter: Cmax of Bictegravir (Free) - Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).
Timepoint [6] 0 0
Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Secondary outcome [1] 0 0
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events - Treatment-emergent adverse events (TEAEs) are defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Timepoint [1] 0 0
First dose date to Day 31
Secondary outcome [2] 0 0
Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities - A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant. Toxicity grade was defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening.
Timepoint [2] 0 0
First dose date to Day 31

Eligibility
Key inclusion criteria
Key

- All Individuals:

- Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening

- Individuals with impaired renal function

- Chronic stable renal impairment without recent clinical change

- Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min

- Moderate: CrCl = 30 - 59 mL/min

- Severe: CrCl = 15 - 29 mL/min

- Healthy individuals

- CrCl = 90 mL/min

Key
Minimum age
18 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- All Individuals:

- Pregnant or lactating females

- HIV positive or chronic hepatitis B infected

- Individuals with impaired renal function

- Chronic liver disease

- Dialysis or anticipated use of dialysis

- Renal transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral
bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched,
healthy controls with normal renal function. Each participant in the renal impairment groups
will be matched for age (± 10 years), gender, and body mass index [BMI (± 20%, 18 = BMI = 40
kg/m^2)] with a participant in the control group.
Trial website
https://clinicaltrials.gov/show/NCT02400307
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications