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

NCT02467335 | Completed Phase 1

• 2 other identifiers: 206280AI438-053
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

  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

Study Arms (4)

Healthy Subjects

ACTIVE COMPARATOR

Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.

Drug: BMS-663068

Hepatic Impaired Subjects - Mild Rating

ACTIVE COMPARATOR

Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.

Drug: BMS-663068

Hepatic Impaired Subjects - Moderate Rating

ACTIVE COMPARATOR

Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.

Drug: BMS-663068

Hepatic Impaired Subjects - Severe Rating

ACTIVE COMPARATOR

Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.

Drug: BMS-663068

Interventions

BMS-663068 DRUG

BMS-663068

Healthy Subjects; Hepatic Impaired Subjects - Mild Rating; Hepatic Impaired Subjects - Moderate Rating; Hepatic Impaired Subjects - Severe Rating

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

GSK Investigational Site

Hamilton, New Jersey, 08690, United States

Location

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

fostemsavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 10, 2015
• Study Start: January 29, 2015
• Primary Completion: October 3, 2015
• Study Completion: October 3, 2015
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)