Single-centre, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Dose of 14C-labeled RO4917523 and an Intravenous Tracer Dose of 13C-labeled RO4917523 in Healthy Male Volunteers

Hoffmann-La Roche0 sites6 target enrollmentApril 2012

ConditionsHealthy Volunteer

InterventionsRO4917523

DrugsRO4917523

Overview

Phase: Phase 1
Intervention: RO4917523
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 6
Primary Endpoint: Elimination: urinary and fecal recovery of total radioactivity
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

May 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

[14C]-labeled RO4917523

Intervention: RO4917523

Outcomes

Primary Outcomes

Elimination: urinary and fecal recovery of total radioactivity

Time Frame: Pre-dose and up to approximately Day 18 post-dose

Plasma concentrations of RO4917523

Time Frame: Pre-dose and up to approximately Day 18 post-dose

Secondary Outcomes

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)