Two-part, Double-blind, Placebo-controlled, Randomized, Parallel-group Study: (Part 1) in Healthy Male Subjects to Assess Safety and Tolerability of Ascending Repeated Oral Doses of BAY1902607 Including Its Effect on the Pharmacokinetics of a Sub-therapeutic Dose of Midazolam (MDZ), Followed by (Part 2) a Two-way Crossover Administration of Four Different Doses of BAY1902607 in Patients With Refractory Chronic Cough to Assess Safety, Tolerability and Efficacy for Proof of Concept
Phase of Trial: Phase I/II
Latest Information Update: 20 Jan 2019
At a glance
- Drugs BAY 1902607 (Primary) ; Midazolam (Primary)
- Indications Cough
- Focus Adverse reactions; Pharmacokinetics; Proof of concept; Therapeutic Use
- Sponsors Bayer
- 25 Oct 2018 Planned End Date changed from 19 Aug 2019 to 16 Sep 2019.
- 25 Oct 2018 Planned primary completion date changed from 31 May 2019 to 19 Aug 2019.
- 19 Jun 2018 Status changed from not yet recruiting to recruiting.