A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)

Study Overview
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Brief Summary
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An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.

Official Title
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An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Oral BMS-663068 (pro-drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (For renal impaired subjects): Classification by renal function based on eGFR Clinical, ECG, and laboratory findings consistent with renal dysfunction BMI of 18.0 to 38.0 kg/m2 inclusive Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control Slightly different inclusion criteria are defined in the protocol for healthy subjects Exclusion Criteria: History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug Any major surgery within 4 weeks of study drug administration. Other protocol defined exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects<br>A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. | Drug: Oral BMS-663068 (pro-drug)<br>* Oral BMS-663068 (pro-drug), metabolized to active BMS-626529<br>|
| Experimental: Mild Renal Impairment Subjects<br>A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. | Drug: Oral BMS-663068 (pro-drug)<br>* Oral BMS-663068 (pro-drug), metabolized to active BMS-626529<br>|
| Experimental: Moderate Renal Impairment Subjects<br>A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. | Drug: Oral BMS-663068 (pro-drug)<br>* Oral BMS-663068 (pro-drug), metabolized to active BMS-626529<br>|
| Experimental: Severe Renal Impairment Subjects<br>A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. | Drug: Oral BMS-663068 (pro-drug)<br>* Oral BMS-663068 (pro-drug), metabolized to active BMS-626529<br>|
| Experimental: End Stage Renal Disease Subjects<br>A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. | Drug: Oral BMS-663068 (pro-drug)<br>* Oral BMS-663068 (pro-drug), metabolized to active BMS-626529<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Renal Impairment on The Primary Endpoints of Cmax | To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529. | Day 1 - Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests. | To assess the safety and tolerability of BMS-663068 in subjects with normal renal function and subjects with impaired renal functions, will be measured by the following secondary endpoints: Incidence of AEs, Serious Adverse Events (SAEs), and AEs leading to discontinuation, and results of vital signs, ECGs, physical examination, and clinical laboratory tests. | Day 1 - Day 5 |