NCT03535662

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

A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Male Participants to Determine the Effect of an Inhibitor of Cytochrome P450 3A and P Glycoprotein on Exposure to Orvepitant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nerre Therapeutics Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetic Study in Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Orvepitant	Single oral dose
DRUG	Itraconazole	Once daily dosing for 10 days

Timeline

• Start date: 2018-06-08
• Primary completion: 2018-08-09
• Completion: 2018-08-09
• First posted: 2018-05-24
• Last updated: 2018-10-11

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study