drugset / Trial / NCT03036501

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

NCT03036501

Phase 1 Completed 6 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Risdiplam Small molecule 18 mg Oral

Indications

No indication recorded.