To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet

Bristol-Myers Squibb41 enrolled

Overview

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.

IND Number: 79,599/101,943 Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses Fixed dose combination (FDC) Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

DCV 3DAA FDCDRUG

BMS-791325DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects in Group A must be in good health and have normal renal function * Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction * Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods Exclusion Criteria: * Subjects in Group A must not have any significant acute or chronic illnesses * Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening * Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months * Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration

Locations (4)

Clinical Pharmacology Of Miami Inc.

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Davita Clinical Research

Minneapolis, Minnesota, United States

New Orleans Center For Clinical Research - Knoxville

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712

Time frame: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12

Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712

Time frame: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12