NCT02229877

A Study to Assess the Effect of Intragastric pH and Fasting on the Pharmacokinetics of Gefapixant (AF-219/MK-7264)

A Study in Healthy Subjects to Assess the Effect of Intragastric pH and Fasting on the Multiple-Dose Pharmacokinetics of AF-219

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (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: determine the effect of stomach pH on the multiple dose pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of gefapixant on various sensory assessments; and, assess the safety and tolerability of gefapixant.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Omeprazole	40 mg oral capsules administered twice daily for 8.5 days
DRUG	Gefapixant	Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 2 days
DRUG	Gefapixant	Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days
DRUG	Gefapixant	Gefapixant oral tablet (150 mg administered as three 50 mg tablets) administered twice daily for 8 days

Timeline

• Start date: 2014-10-06
• Primary completion: 2015-05-14
• Completion: 2015-05-22
• First posted: 2014-09-03
• Last updated: 2022-07-22