A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838
NCT ID: NCT01510899
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2011-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Healthy Subjects Arm
RO4917838
Single dose of RO4917838
Renal Impaired Subjects Arm
RO4917838
Single dose of RO4917838
Interventions
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RO4917838
Single dose of RO4917838
RO4917838
Single dose of RO4917838
Eligibility Criteria
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Inclusion 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
* 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)
18 Years
70 Years
ALL
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Rennes, , France
Moscow, , Russia
Moscow, , Russia
Countries
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Other Identifiers
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BP25261
Identifier Type: -
Identifier Source: org_study_id