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

NCT ID: NCT02467335

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-29

Study Completion Date

2015-10-03

Brief Summary

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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

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Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Subjects

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

Group Type ACTIVE_COMPARATOR

BMS-663068

Intervention Type DRUG

BMS-663068

Hepatic Impaired Subjects - Mild Rating

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

Group Type ACTIVE_COMPARATOR

BMS-663068

Intervention Type DRUG

BMS-663068

Hepatic Impaired Subjects - Moderate Rating

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

Group Type ACTIVE_COMPARATOR

BMS-663068

Intervention Type DRUG

BMS-663068

Hepatic Impaired Subjects - Severe Rating

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

Group Type ACTIVE_COMPARATOR

BMS-663068

Intervention Type DRUG

BMS-663068

Interventions

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BMS-663068

BMS-663068

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Hamilton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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AI438-053

Identifier Type: OTHER

Identifier Source: secondary_id

206280

Identifier Type: -

Identifier Source: org_study_id