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

Study Overview
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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.

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

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-663068


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Subjects<br>Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1. | Drug: BMS-663068<br>* BMS-663068<br>|
| Active Comparator: Hepatic Impaired Subjects - Mild Rating<br>Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. | Drug: BMS-663068<br>* BMS-663068<br>|
| Active Comparator: Hepatic Impaired Subjects - Moderate Rating<br>Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. | Drug: BMS-663068<br>* BMS-663068<br>|
| Active Comparator: Hepatic Impaired Subjects - Severe Rating<br>Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. | Drug: BMS-663068<br>* BMS-663068<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 |