check_circleStudy Completed

Cough

Repeat doses of BAY1902607 in healthy males and proof of concept in chronic cough patients

Trial purpose

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).

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
59
Trial Dates
May 2018 - October 2019
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Filapixant (BAY1902607)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medicines Evaluation UnitManchester, M23 9GP, United Kingdom
Completed
University Hospital of South ManchesterManchester, M23 9LT, United Kingdom
Completed
Castle Hill HospitalCottingham, HU16 5JQ, United Kingdom
Completed
King's College Hospital - NHS Foundation TrustLondon, SE5 9RS, United Kingdom
Completed
Birmingham Heartlands HospitalBirmingham, B9 5SS, United Kingdom
Completed
IsalaZWOLLE, 8025 AB, Netherlands
Completed
Catharina ZiekenhuisEINDHOVEN, 5623 EJ, Netherlands
Completed
Queen's UniversityBelfast, BT9 7BL, United Kingdom

Primary Outcome

  • Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 1
    date_rangeTime Frame:
    Approximately 5 weeks
  • Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 2
    date_rangeTime Frame:
    Approximately 12 weeks
  • AUC of midazolam without BAY1902607
    Part 1
    date_rangeTime Frame:
    At Day -1
  • AUC of midazolam in combination with BAY1902607
    Part 1
    date_rangeTime Frame:
    At Day 13
  • Cmax of midazolam in combination with BAY1902607
    Part 1
    date_rangeTime Frame:
    At Day 13
  • Cmax of midazolam without BAY1902607
    Part 1
    date_rangeTime Frame:
    At Day -1
  • Number of Coughs Experienced by the Patient Within a 24-hour Period (24- hour cough count/hour) in Part 2
    Part 2: Coughs monitored by VitaloJAK cough recorder (Vitalograph)
    date_rangeTime Frame:
    24 hours

Trial design

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 Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
6