drugset / Trial / NCT03535662

A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers

NCT03535662 ↗

Phase 1 Completed 16 enrolled Nerre Therapeutics Ltd.
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

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule — —
Subject Orvepitant Small molecule 20 mg Oral

Indications

No indication recorded.