A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO4917838

Study type

Interventional

Funder types

Industry

Identifiers

NCT01510899

BP25261

Details and patient eligibility

About

This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.

Enrollment

12 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

General criteria

Body mass index (BMI) between 18 and 32 kg/m2

Criteria applying to renal impaired subjects

Adult subjects, 18-65 years of age
Part 1: Subjects with end stage renal disease (ESRD), not on dialysis
Part 2: Subjects with severe, moderate or mild renal impairment
Stable renal function

Criteria applying to healthy subjects

Adult subjects, 18-70 years of age

Exclusion criteria

General criteria

Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk
Any condition which could relapse during or immediately after the study
History of alcohol or drug abuse

Criteria applying to renal impaired subjects

Evidence of unstable clinically significant disease other than renal impairment
Clinically significant liver disease
Any other major illness (with the exception of renal impairment) within 4 weeks prior to study start

Criteria applying to healthy subjects