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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Hepatitis C

Treatments

Drug: Asunaprevir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01886599

AI447-033

Details and patient eligibility

About

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

Full description

Primary Purpose:

Other: 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

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

48 participants in 5 patient groups

Arm A: Subjects with normal renal function

Experimental group

Description: