drugset / Trial / NCT05110027
Enpatoran Human Mass Balance and Absolute Bioavailability Study
Phase 1
Completed
7 enrolled
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of Period 1 of this study is to provide a definitive quantitative characterization of the mass balance, and rates and routes of excretion of enpatoran, and to determine and quantify enpatoran and its metabolites in excreta (urine and feces) and plasma. The purpose of Period 2 of this study is to determine the absolute oral bioavailability of enpatoran. Total minimum duration of study participation for each participant is approximately 50 days.
Timeline
- Start
- 2021-11-05
- Primary completion
- 2021-12-24
- Completion
- 2021-12-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enpatoran | Small molecule | — | Oral |
Indications
No indication recorded.