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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO4917838

• Registration Number: NCT01510899
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Subjects Arm	RO4917838	-
Renal Impaired Subjects Arm	RO4917838	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under concentration time curve of RO4917838	Days 1-16

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	9 weeks