A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
NCT ID: NCT01592890
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
6 participants
INTERVENTIONAL
2012-04-30
2012-05-31
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
SINGLE_GROUP
NONE
Study Groups
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[14C]-labeled RO4917523
RO4917523
\[14C\]-labeled RO4917523, single oral dose
RO4917523
\[13C\]-labeled RO4917523, single intravenous tracer dose
Interventions
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RO4917523
\[14C\]-labeled RO4917523, single oral dose
RO4917523
\[13C\]-labeled RO4917523, single intravenous tracer dose
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 18.0 to 32.0 kg/m2
* Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG
* Medical history without major pathology
* Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug
Exclusion Criteria
* Smoking (within 60 days prior to drug administration until the follow-up visit)
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
* Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug
* Infrequent bowel movements (less than once per 2 days)
* Participation in another ADME study with a radiation burden \>0,1 mSv in the period of 1 years before the start of the study
* Positive screen for drugs of abuse
* Average intake of more than 24 units of alcohol per week
* Positive for hepatitis B, hepatitis C or HIV infection
18 Years
65 Years
MALE
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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Zuidlaren, , Netherlands
Countries
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Other Identifiers
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2011-004597-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP27854
Identifier Type: -
Identifier Source: org_study_id