Status:
COMPLETED
A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 RO491783...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01510899
Start Date
October 1 2011
End Date
March 1 2012
Last Update
November 2 2016
Active Locations (3)
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1
Rennes, France, 35042
2
Moscow, Russia, 117192
3
Moscow, Russia, 117292