Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects

A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.

Study Overview

• Status: Completed
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: BMS-663068

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hamilton, New Jersey, United States, 08690
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females, ages 18 to 70 years, inclusive
• BMI: 18.5 to 38 kg/m2
• Body weight great or equal to 45.5 kg
• Subjects with hepatic impairment
• Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
• Healthy subjects to the extent possible matched to the first four subjects with hepatic impairment with regard to age, body weight, and sex, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

• Any major surgery within 4 weeks of study drug administration
• Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
• Subject has required additional medication for hepatic encephalopathy within 12 months (6 months for severe hepatic impairment) prior to dosing
• Presence of severe ascites or edema in subjects, as judged by the PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Subjects; Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.	Drug: BMS-663068; BMS-663068
Active Comparator: Hepatic Impaired Subjects - Mild Rating; Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.	Drug: BMS-663068; BMS-663068
Active Comparator: Hepatic Impaired Subjects - Moderate Rating; Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.	Drug: BMS-663068; BMS-663068
Active Comparator: Hepatic Impaired Subjects - Severe Rating; Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.	Drug: BMS-663068; BMS-663068

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).	5 days
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite).	5 days
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite).	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety and tolerability of a 600-mg single dose of BMS-663068 in subjects with hepatic impairment and in healthy subjects through analysis of adverse events.	Adverse events will be arranged by system organ class, preferred term and hepatic function group. In addition, electrocardiogram readings will be summarized by time point relative to hepatic function group, and investigator-identified abnormalities, if present, will be listed.	5 days
The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters.		5 days

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2015
• Primary Completion (Actual): October 3, 2015
• Study Completion (Actual): October 3, 2015

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Fostemsavir
• Other Study ID Numbers: 206280; AI438-053 (Other Identifier: Bristol-Myers Squibb)