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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-663068

Study type: Interventional

Funder types: Industry

Identifiers

NCT02467335

AI438-053 (Other Identifier)

206280

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 4 patient groups

Healthy Subjects

Active Comparator group

Description:

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

Treatment:

Drug: BMS-663068

Hepatic Impaired Subjects - Mild Rating

Active Comparator group

Description:

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

Treatment:

Drug: BMS-663068

Hepatic Impaired Subjects - Moderate Rating

Active Comparator group

Description:

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

Treatment:

Drug: BMS-663068

Hepatic Impaired Subjects - Severe Rating

Active Comparator group

Description:

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

Treatment:

Drug: BMS-663068