Clinical trial NCT01631422: A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics: Elimination of RO4602522: urine/feces concentration
timeFrame: Predose, Day 1, 2 and 3
measure: Pharmacokinetics: Plasma concentration of RO4602522/metabolite
timeFrame: Predose, Day 1, 2 and 3
Secondary outcomes:
measure: Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration
timeFrame: Predose, Day 1, 2 and 3
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: