drugset / Trial / NCT03535662
A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers
Non-randomizedSequentialOpen-labelTreatment
Summary
A Phase 1 study to assess the effect of itraconazole, a strong inhibitor of CYP3A and P-glycoprotein, on the pharmacokinetics (PK) of orvepitant in healthy male volunteers. Subjects will receive two single doses of 20mg orvepitant, once alone and once in combination with repeat doses of itraconazole. All subjects will follow the same sequence - orvepitant alone followed by orvepitant in combination with itraconazole.
Timeline
- Start
- 2018-06-08
- Primary completion
- 2018-08-09
- Completion
- 2018-08-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | — | — |
| Subject | Orvepitant | Small molecule | 20 mg | Oral |
Indications
No indication recorded.