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

Completed · Phase 1

Conditions studied: Hepatitis C

In brief

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

Key facts

Study ID: NCT02108639
Run by: Bristol-Myers Squibb
People needed: 41
Starts: 2014-04-01
Expected to finish: 2014-06-01
Last updated by the study team: 2014-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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