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NCT Number: NCT02400307

Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

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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Key information

Conditions

HIV

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Auckland Clinical Studies Limited, Grafton, Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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 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.

Treatment and study plan

Bictegravir

Drug

75 mg tablet administered orally

Other names: GS-9883

Primary outcomes

  1. Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)

    Time frame: 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

    AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.

  2. PK Parameter: AUCinf of Bictegravir (Free)

    Time frame: 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

    Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).

  3. PK Parameter: AUClast of Bictegravir (Total)

    Time frame: 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

    AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.

  4. PK Parameter: AUClast of Bictegravir (Free)

    Time frame: 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

    Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).

  5. PK Parameter: Cmax of Bictegravir (Total)

    Time frame: 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

    Cmax is defined as the maximum observed plasma concentration of drug.

  6. PK Parameter: Cmax of Bictegravir (Free)

    Time frame: 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

    Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).

Secondary outcomes

  1. Percentage of Participants Who Experienced Treatment-Emergent Adverse Events

    Time frame: First dose date to Day 31

    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.

  2. Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities

    Time frame: First dose date to Day 31

    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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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