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

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-663068

• Registration Number: NCT02467335
• Lead Sponsor: ViiV Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-29
• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Primary Completion: 2015-10-03
• Study Completion: 2015-10-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	BMS-663068	Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
Hepatic Impaired Subjects - Mild Rating	BMS-663068	Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Hepatic Impaired Subjects - Moderate Rating	BMS-663068	Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Hepatic Impaired Subjects - Severe Rating	BMS-663068	Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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.
The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters.	5 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Hamilton, New Jersey, United States