Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir

Criteria

Inclusion Criteria:

• Group A: Subjects with normal renal function

• Group B: Patients with end stage renal disease

• Group C: Patients with mild renal impairment

• Group D: Patients with moderate renal impairment

• Group E: Patients with severe renal impairment

Exclusion Criteria:

• History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease

• Hepatitis B or C

• Human Immunodeficiency Virus (HIV)

• Recent gastrointestinal disease