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A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01631422
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO4602522 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Single-Center, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Radio-labeled RO4602522 in Healthy Male Volunteers
Study Start Date : June 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm Drug: RO4602522
Single radiolabeled dose


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics: Elimination of RO4602522: urine/feces concentration [ Time Frame: Predose, Day 1, 2 and 3 ]
  2. Pharmacokinetics: Plasma concentration of RO4602522/metabolite [ Time Frame: Predose, Day 1, 2 and 3 ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration [ Time Frame: Predose, Day 1, 2 and 3 ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers, 35 to 55 years of age, inclusive
  • Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
  • A body mass index (BMI) between 18 to 30 kg/m2 inclusive
  • Male volunteers and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose.
  • Able to participate and willing to give written informed consent and to comply with the study restrictions.
  • Non-smokers or have not smoked since at least 3 months prior to screening

Exclusion Criteria:

  • If capable of reproduction, unwilling to use an effective form of contraception
  • Suspicion of regular consumption of drug of abuse and/or positive drug or alcohol screen
  • Infection with hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2
  • Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg
  • Resting pulse rate greater than 90 or less than 45 beats per minute
  • Clinically significant abnormalities in laboratory test results
  • Participation in an investigational drug or device study within 90 days prior to screening
  • Donation of blood within 3 months prior to screening
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Contacts and Locations
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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): NCT01631422


Locations
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Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01631422    
Other Study ID Numbers: BP28235
2012-000587-26 ( EudraCT Number )
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016