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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

Trial Profile

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

Recruiting
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
  • Most Recent Events

    • 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.
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