drugset / Trial / NCT03664453
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.
Timeline
- Start
- 2018-10-29
- Primary completion
- 2018-11-20
- Completion
- 2018-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omaveloxolone | Small molecule | 50 mg | — |
| Subject | Omaveloxolone | Small molecule | 100 mg | — |
| Subject | Omaveloxolone | Small molecule | 150 mg | — |
Indications
No indication recorded.