A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631422
• Other study ID #: BP28235
• Secondary ID: 2012-000587-26
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2012
• Last updated: November 1, 2016
• Start date: June 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4602522
Single radiolabeled dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Elimination of RO4602522: urine/feces concentration		Predose, Day 1, 2 and 3	No
Primary	Pharmacokinetics: Plasma concentration of RO4602522/metabolite		Predose, Day 1, 2 and 3	No
Secondary	Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration		Predose, Day 1, 2 and 3	No