NCT02790840

A Multiple-Dose Pharmacokinetics Study of Three Gefapixant (AF-219/MK-7264) Formulations

A Study in Healthy Subjects to Assess the Multiple- Dose Pharmacokinetics of Three AF-219 Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK of three gefapixant formulations; and, to assess the safety and tolerability of gefapixant.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Omeprazole	20 mg oral capsules administered once daily for 10 days
DRUG	Omeprazole	40 mg oral capsules administered twice daily for 10 days
DRUG	Gefapixant	Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days
DRUG	Gefapixant	Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days

Timeline

• Start date: 2016-05-16
• Primary completion: 2016-06-15
• Completion: 2016-06-21
• First posted: 2016-06-06
• Last updated: 2017-04-18

Locations

1 site across 1 country: United States