check_circleStudy Completed
Cough
Bayer Identifier:
19430
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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).
-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
AllAge
18 - N/ATrial summary
Enrollment Goal
59Trial Dates
May 2018 - October 2019Phase
Phase 1/Phase 2Could I Receive a placebo
NoProducts
Filapixant (BAY1902607)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medicines Evaluation Unit | Manchester, M23 9GP, United Kingdom |
Completed | University Hospital of South Manchester | Manchester, M23 9LT, United Kingdom |
Completed | Castle Hill Hospital | Cottingham, HU16 5JQ, United Kingdom |
Completed | King's College Hospital - NHS Foundation Trust | London, SE5 9RS, United Kingdom |
Completed | Birmingham Heartlands Hospital | Birmingham, B9 5SS, United Kingdom |
Completed | Isala | ZWOLLE, 8025 AB, Netherlands |
Completed | Catharina Ziekenhuis | EINDHOVEN, 5623 EJ, Netherlands |
Completed | Queen's University | Belfast, BT9 7BL, United Kingdom |
Primary Outcome
- Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 1date_rangeTime Frame:Approximately 5 weeks
- Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 2date_rangeTime Frame:Approximately 12 weeks
- AUC of midazolam without BAY1902607Part 1date_rangeTime Frame:At Day -1
- AUC of midazolam in combination with BAY1902607Part 1date_rangeTime Frame:At Day 13
- Cmax of midazolam in combination with BAY1902607Part 1date_rangeTime Frame:At Day 13
- Cmax of midazolam without BAY1902607Part 1date_rangeTime Frame:At Day -1
- Number of Coughs Experienced by the Patient Within a 24-hour Period (24- hour cough count/hour) in Part 2Part 2: Coughs monitored by VitaloJAK cough recorder (Vitalograph)date_rangeTime Frame:24 hours
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
6