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A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01631422
Collaborator
(none)
6
Enrollment
1
Location
1
Arm

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jun 1, 2012
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

Drug: RO4602522
Single radiolabeled dose

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics: Elimination of RO4602522: urine/feces concentration [Predose, Day 1, 2 and 3]

  2. Pharmacokinetics: Plasma concentration of RO4602522/metabolite [Predose, Day 1, 2 and 3]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Zuidlaren Netherlands 9471 GP

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01631422
Other Study ID Numbers:
  • BP28235
  • 2012-000587-26
First Posted:
Jun 29, 2012
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016