A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01631422
First received: June 20, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This single-center, open-label study will investigate the pharmacokinetics and e limination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.


Condition Intervention Phase
Healthy Volunteer
Drug: RO4602522
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Elimination of RO4602522: urine/feces concentration [ Time Frame: Predose, Day 1, 2 and 3 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma concentration of RO4602522/metabolite [ Time Frame: Predose, Day 1, 2 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration [ Time Frame: Predose, Day 1, 2 and 3 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO4602522
Single radiolabeled dose

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631422

Locations
Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01631422     History of Changes
Other Study ID Numbers: BP28235, 2012-000587-26
Study First Received: June 20, 2012
Last Updated: August 4, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on September 16, 2014