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Clinical Trials/NCT01510899
NCT01510899
Completed
Phase 1

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

Hoffmann-La Roche0 sites12 target enrollmentOctober 2011
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ConditionsHealthy Volunteer
InterventionsRO4917838
DrugsRO4917838

Overview

Phase
Phase 1
Intervention
RO4917838
Conditions
Healthy Volunteer
Sponsor
Hoffmann-La Roche
Enrollment
12
Primary Endpoint
Pharmacokinetics: Area under concentration time curve of RO4917838
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
March 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Arms & Interventions

Healthy Subjects Arm

Intervention: RO4917838

Renal Impaired Subjects Arm

Intervention: RO4917838

Outcomes

Primary Outcomes

Pharmacokinetics: Area under concentration time curve of RO4917838

Time Frame: Days 1-16

Secondary Outcomes

  • Safety: Incidence of adverse events(9 weeks)

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