drugset / Trial / NCT05562362
Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension
RandomizedSequentialOpen-labelTreatment
Summary
This single-center, open-label, randomized, single and multiple-dose, 3-way sequential study at 3 dose levels will be performed in healthy subjects. Subjects will be randomized to 1 of the 3 dose levels. In each dose level, subjects will be administered a single dose in the fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess Pharmacokinetics (PK) following multiple dosing.
Timeline
- Start
- 2020-06-18
- Primary completion
- 2020-11-12
- Completion
- 2020-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sparsentan | Small molecule | 200 mg | — |
| Subject | Sparsentan | Small molecule | 400 mg | — |
| Subject | Sparsentan | Small molecule | 800 mg | — |
Indications
No indication recorded.