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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01510899
First received: January 12, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This open-label, single-dose, parallel-group study will investigate the pharmaco kinetics and safety of RO4917838 in healthy and renal impaired subjects. Subject s will receive a single dose of RO4917838.


Condition Intervention Phase
Healthy Volunteer
Drug: RO4917838
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510899

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01510899     History of Changes
Other Study ID Numbers: BP25261
Study First Received: January 12, 2012
Last Updated: August 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 15, 2014