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

NCT03535168 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2021-02-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535168 on ClinicalTrials.gov