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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510899
First Posted: January 18, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510899


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01510899     History of Changes
Other Study ID Numbers: BP25261
First Submitted: January 12, 2012
First Posted: January 18, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases