drugset / Trial / NCT04638803
Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
Non-randomizedSequentialOpen-labelOther
Summary
The goal of the present study is to confirm in humans the in-vivo bioconversion of a Prodrug (PRX-P4-003) to (-)-fencamfamine (FCF) the active moiety when orally administered as a single microdose. A second component of the study will evaluate effect of food on pharmacokinetics of PRX-P4-003.
Timeline
- Start
- 2021-02-25
- Primary completion
- 2021-10-30
- Completion
- 2021-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FENCAMFAMIN | Small molecule | 40 ug | Oral |
| Subject | PRX-P4-003 | Unknown | 100 ug | Oral |
Indications
No indication recorded.