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

Phase 1 Completed 18 enrolled Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Celerion · collab

NaSingle-groupSingle-blindTreatment

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.

Timeline

Start: 2014-10-06
Primary completion: 2015-05-14
Completion: 2015-05-22

Publications

Results Gupta P, Hussain A, Ford AP, Smith S, Nussbaum JC, Stoch A, Iwamoto M. Clinical Formulation Bridging of Gefapixant, a P2X3-Receptor Antagonist, for the Treatment of Chronic Cough. Clin Pharmacol Drug Dev. 2022 Sep;11(9):1054-1067. doi: 10.1002/cpdd.1105. Epub 2022 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefapixant	Small molecule	25 mg	Oral
Subject	Gefapixant	Small molecule	50 mg	Oral
Subject	Gefapixant	Small molecule	150 mg	Oral
Background	Omeprazole	Other / unclassified	40 mg	Oral

Indications

No indication recorded.