NCT03535168

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	BAY1902607	3 different doses over the course of part 1 and 4 different doses over the course of part 2.
DRUG	Matching placebo	Matching placebo for BAY1902607
DRUG	Midazolam	Part 1: The subjects will initially (Day -1) receive a sub-therapeutic dose of 1 mg midazolam as solution in the morning.

Timeline

• Start date: 2018-05-29
• Primary completion: 2019-09-25
• Completion: 2019-10-11
• First posted: 2018-05-24
• Last updated: 2021-02-10

Locations

8 sites across 2 countries: Netherlands, United Kingdom