Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- ViiV Healthcare
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy Subjects
Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1.
Intervention: BMS-663068 (Drug)
Hepatic Impaired Subjects - Mild Rating
Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Intervention: BMS-663068 (Drug)
Hepatic Impaired Subjects - Moderate Rating
Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Intervention: BMS-663068 (Drug)
Hepatic Impaired Subjects - Severe Rating
Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1.
Intervention: BMS-663068 (Drug)
Outcomes
Primary Outcomes
The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).
Time Frame: 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).
Time Frame: 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).
Time Frame: 5 days
Secondary Outcomes
- 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)