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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003461-26 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [^14C]-Risdiplam | Experimental | Participants will be administered with [^14C]-Risdiplam solution orally under fasted conditions on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [^14C]-Risdiplam | Drug | [^14C]-Risdiplam 18 mg oral solution with approximately 0.75 megabecquerel MBq (20 microcuries [μCi]) of [14C]-labeled Risdiplam. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Dose Recovered as Total [14C]-radioactivity in Urine | Day 1 to Day 36 | |
| Cumulative Urinary Amount of Total [14C]-Radioactivity in Urine | Day 1 to Day 36 | |
| Percentage of Dose Recovered as Total [14C]-radioactivity in Feces | Day 1 to Day 36 | |
| Maximum Observed Plasma Concentration (Cmax) of Risdiplam | Day 1 to Day 36 | |
| Time to Maximum Observed Plasma Concentration of Risdiplam (Tmax) | Day 1 to Day 36 | |
| Area Under the Plasma Concentration-time Curve from Time 0 to Last Measurable Concentration Time Point (AUC0-last) | Day 1 to Day 36 | |
| Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) | Day 1 to Day 36 | |
| Apparent Terminal Elimination Half-Life (t1/2) | Day 1 to Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Up to 10 weeks | |
| Percentage of Participants with Laboratory, ECGs, Ophthalmological Assessments, And Vital Signs Abnormalities | Up to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pra International Group B.V | Groningen | 9728 NZ | Netherlands |
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