Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

NCT02400307 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: GS-US-141-14792015-000898-12
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 7

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.

Conditions

HIV

Keywords

Phase 1; Renally Impaired

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)

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

  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

• PK Parameter: AUCinf of Bictegravir (Free)

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

  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

• 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.

  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

• PK Parameter: AUClast of Bictegravir (Free)

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

  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

• PK Parameter: Cmax of Bictegravir (Total)

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

  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

• PK Parameter: Cmax of Bictegravir (Free)

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

  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 Outcomes (2)

• Percentage of Participants Who Experienced Treatment-Emergent Adverse Events

  First dose date to Day 31

• Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities

  First dose date to Day 31

Study Arms (3)

Severe Renal Impairment

EXPERIMENTAL

Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir.

Drug: Bictegravir

Moderate Renal Impairment

EXPERIMENTAL

Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir.

Drug: Bictegravir

Mild Renal Impairment

EXPERIMENTAL

Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir.

Drug: Bictegravir

Interventions

Bictegravir DRUG

75 mg tablet administered orally

Also known as: GS-9883

Mild Renal Impairment; Moderate Renal Impairment; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (7)

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Prism Clinical Research

Saint Paul, Minnesota, 55114, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Auckland Clinical Studies Limited

Grafton, Auckland, 1010, New Zealand

Location

Christchurch Clinical Studies Trust

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

bictegravir

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 27, 2015
• Study Start: April 17, 2015
• Primary Completion: July 6, 2015
• Study Completion: July 13, 2015
• Last Updated: October 11, 2019
• Results First Posted: October 11, 2019

Record last verified: 2019-09

Locations

US (5); NZ (2)