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A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants

NCT03036501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-10-04

No results posted yet for this study

Summary

This is an open-label, non-randomized study investigating the excretion balance, PK and metabolism of a single oral dose of \[14C\]-labeled Risdiplam (RO7034067) in healthy male participants. This study will assess the characterize mass balance, routes and rates of elimination of \[14C\]-labeled Risdiplam (RO7034067), using conventional analytical methods and assess the pharmacokinetics of total drug related \[14C\]-radioactivity, Risdiplam (RO7034067) and its metabolite(s).

Conditions

  • Healthy

Interventions

DRUG

[^14C]-Risdiplam

\[\^14C\]-Risdiplam 18 mg oral solution with approximately 0.75 megabecquerel MBq (20 microcuries \[μCi\]) of \[14C\]-labeled Risdiplam.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT03036501 on ClinicalTrials.gov