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

Bristol-Myers Squibb (BMS) logo

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:
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Treatment:
Drug: Asunaprevir
Arm B: Subjects with end stage renal disease
Experimental group
Description:
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Treatment:
Drug: Asunaprevir
Arm C: Subjects with mild renal impairment
Experimental group
Description:
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Treatment:
Drug: Asunaprevir
Arm D: Subjects with moderate renal impairment
Experimental group
Description:
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Treatment:
Drug: Asunaprevir
Arm E: Subjects with severe renal impairment
Experimental group
Description:
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Treatment:
Drug: Asunaprevir

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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