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

NCT01592890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

RO4917523

\[14C\]-labeled RO4917523, single oral dose

DRUG

RO4917523

\[13C\]-labeled RO4917523, single intravenous tracer dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592890 on ClinicalTrials.gov