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

A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510899

Enrollment

Registered

2012-01-18

Start date

2011-10-31

Completion date

2012-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

DRUGRO4917838

Single dose of RO4917838

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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 * History of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Area under concentration time curve of RO4917838	Days 1-16

Secondary

Measure	Time frame
Safety: Incidence of adverse events	9 weeks

Countries

France, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026