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A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

NCT ID: NCT01631422

Last Updated: 2016-11-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

RO4602522

Intervention Type DRUG

Single radiolabeled dose

Interventions

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RO4602522

Single radiolabeled dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2012-000587-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28235

Identifier Type: -

Identifier Source: org_study_id