Repeat Doses of BAY1902607 in Healthy Males and Proof of Concept in Chronic Cough Patients

Phase 1/2 Completed 59 enrolled Bayer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objectives of this study: * To investigate the safety and tolerability of ascending repeated oral doses of BAY1902607 in healthy subjects (Part 1). * To investigate the effect of BAY1902607 on the pharmacokinetics (PK) of a sub-therapeutic 1 mg dose of midazolam (Part 1). * To investigate the safety, tolerability and efficacy of BAY1902607 in patients with refractory chronic cough (Part 2).

Timeline

Start: 2018-05-29
Primary completion: 2019-09-25
Completion: 2019-10-11

Publications

Friedrich C, Francke K, Birring SS, van den Berg JWK, Marsden PA, McGarvey L, Turner AM, Wielders P, Gashaw I, Klein S, Morice AH. The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial. Respir Res. 2023 Apr 11;24(1):109. doi: 10.1186/s12931-023-02384-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	1 mg	—
Subject	filapixant	Unknown	20 mg	Oral
Subject	filapixant	Unknown	80 mg	Oral
Subject	filapixant	Unknown	150 mg	Oral
Subject	filapixant	Unknown	250 mg	Oral

Indications

No indication recorded.