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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
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2015-000898-12
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Secondary ID [2]
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GS-US-141-1479
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)
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Assessment method [1]
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AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
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Timepoint [1]
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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
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Primary outcome [2]
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PK Parameter: AUCinf of Bictegravir (Free)
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Assessment method [2]
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Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).
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Timepoint [2]
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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
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Primary outcome [3]
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PK Parameter: AUClast of Bictegravir (Total)
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Assessment method [3]
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AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
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Timepoint [3]
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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
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Primary outcome [4]
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PK Parameter: AUClast of Bictegravir (Free)
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Assessment method [4]
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Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).
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Timepoint [4]
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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
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Primary outcome [5]
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PK Parameter: Cmax of Bictegravir (Total)
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Assessment method [5]
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Cmax is defined as the maximum observed plasma concentration of drug.
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Timepoint [5]
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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
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Primary outcome [6]
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PK Parameter: Cmax of Bictegravir (Free)
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Assessment method [6]
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Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).
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Timepoint [6]
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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
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Secondary outcome [1]
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Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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First dose date to Day 31
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Secondary outcome [2]
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Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
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Assessment method [2]
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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.
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Timepoint [2]
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First dose date to Day 31
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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
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Minimum age
18
Years
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Maximum age
79
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/04/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/07/2015
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Sample size
Target
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Accrual to date
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Final
19
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Minnesota
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Country [3]
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United States of America
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State/province [3]
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Tennessee
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Country [4]
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New Zealand
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State/province [4]
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Auckland
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Country [5]
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New Zealand
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State/province [5]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02400307
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02400307
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