A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4602522

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands, 9471 GP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: RO4602522; Single radiolabeled dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Elimination of RO4602522: urine/feces concentration	Predose, Day 1, 2 and 3
Pharmacokinetics: Plasma concentration of RO4602522/metabolite	Predose, Day 1, 2 and 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration	Predose, Day 1, 2 and 3

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP28235; 2012-000587-26 (EudraCT Number)