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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 12, 2012
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Healthy Volunteer Drug: RO4917838 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area under concentration time curve of RO4917838 [ Time Frame: Days 1-16 ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 9 weeks ]

Enrollment: 12
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Subjects Arm Drug: RO4917838
Single dose of RO4917838
Experimental: Renal Impaired Subjects Arm Drug: RO4917838
Single dose of RO4917838


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01510899

Rennes, France, 35042
Russian Federation
Moscow, Russian Federation, 117192
Moscow, Russian Federation, 117292
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01510899     History of Changes
Other Study ID Numbers: BP25261
Study First Received: January 12, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on August 21, 2017