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

Phase 1 Completed 14 enrolled Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Celerion · collab

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2015-07-07
Primary completion: 2015-08-04
Completion: 2015-08-11

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	Omeprazole	Other / unclassified	20 mg	Oral

Indications

No indication recorded.