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Radio-labeled rodatristat ethyl · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Radio-labeled rodatristat ethyl 600 mg | EXPERIMENTAL | Single dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of \[12C\]-rodatristat ethyl and \[14C\]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity |
| Name | Type | Description |
|---|---|---|
| Radio-labeled rodatristat ethyl 600 mg | DRUG | Single dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of \[12C\]-rodatristat ethyl and \[14C\]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity |
Inclusion Criteria: * Healthy males aged 18 to 55 years, inclusive. * Healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, cardiac monitoring, and clinical laboratory test results. ...
Radio-labeled rodatristat ethyl is an investigational small molecule developed by Roivant Sciences Ltd. (ticker: ROIV). It is a carbon-14 labeled version of rodatristat ethyl used in a Phase 1 clinical trial to study pharmacokinetics and excretion in healthy male volunteers. The drug has not been approved and remains in clinical development.
Radio-labeled rodatristat ethyl is being developed by Roivant Sciences Ltd., which trades under the ticker ROIV. The company is responsible for the clinical development program, including the Phase 1 trial of the radio-labeled compound.
Radio-labeled rodatristat ethyl is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA or any regulatory agency.
Radio-labeled rodatristat ethyl has been studied in one completed Phase 1 trial, NCT05006118, titled "Pharmacokinetics and Excretion of Oral [14C]-Rodatristat Ethyl." The trial enrolled 5 healthy male volunteers in the United States and was uncontrolled, non-randomized, and not double-blind.