A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO4917523

• Registration Number: NCT01592890
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral \[14C\]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of \[14C\]-labeled RO4917523 and an intravenous tracer dose of \[13C\]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Male adults, 18 to 65 years of age inclusive
• Body mass index (BMI) 18.0 to 32.0 kg/m2
• Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG
• Medical history without major pathology
• Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug

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Exclusion Criteria

• History of relevant drug and or food allergies
• Smoking (within 60 days prior to drug administration until the follow-up visit)
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
• Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug
• Infrequent bowel movements (less than once per 2 days)
• Participation in another ADME study with a radiation burden >0,1 mSv in the period of 1 years before the start of the study
• Positive screen for drugs of abuse
• Average intake of more than 24 units of alcohol per week
• Positive for hepatitis B, hepatitis C or HIV infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-labeled RO4917523	RO4917523	-

Primary Outcome Measures

Name	Time	Method
Elimination: urinary and fecal recovery of total radioactivity	Pre-dose and up to approximately Day 18 post-dose
Plasma concentrations of RO4917523	Pre-dose and up to approximately Day 18 post-dose

Secondary Outcome Measures

Name	Time	Method
Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling	Pre-dose and up to approximately Day 18 post-dose
Absolute bioavailability: Area under the concentration-time curve (AUC)	Pre-dose and up to approximately Day 18 post-dose