check_circleStudy Completed
Cough
Bayer Identifier:
18184
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Repeat doses of BAY 1817080 in healthy males & Proof of concept in chronic cough patients
Trial purpose
To investigate the safety and tolerability of ascending repeated oral doses of BAY1817080 in healthy volunteers(Part1).
To investigate the safety, tolerability and efficacy of BAY1817080 in patients with refractory chronic cough(Part2).
To investigate the safety, tolerability and efficacy of BAY1817080 in patients with refractory chronic cough(Part2).
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
87Trial Dates
December 2017 - June 2019Phase
Phase 1/Phase 2Could I Receive a placebo
YesProducts
Eliapixant (BAY1817080)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medicines Evaluation Unit | Manchester, M23 9QZ, United Kingdom |
Completed | Castle Hill Hospital | Cottingham, HU16 5JQ, United Kingdom |
Completed | University Hospital of South Manchester | Manchester, M23 9LT, United Kingdom |
Completed | King's College Hospital - NHS Foundation Trust | London, SE5 9RS, United Kingdom |
Completed | North Tyneside General Hospital | North Shields, NE29 8NH, United Kingdom |
Completed | Queen's University | Belfast, BT9 7AB, United Kingdom |
Completed | Birmingham Heartlands Hospital | Birmingham, B9 5SS, United Kingdom |
Primary Outcome
- Frequency of treatment emergent adverse events in study part 1date_rangeTime Frame:Up to 5 weeks
- Severity of treatment emergent adverse events in study 1The intensity of an AE is classified according to the following categories: • Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. • Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. • Severe: A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical statusdate_rangeTime Frame:Up to 5 weeks
- Frequency of treatment emergent adverse events in study part 2date_rangeTime Frame:Up to 12 weeks
- Severity of treatment emergent adverse events in study part 2The intensity of an AE is classified according to the following categories: • Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. • Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. • Severe: A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical statusdate_rangeTime Frame:Up to 12 weeks
- 24-hour cough countsdate_rangeTime Frame:At week 1 in period A
- 24 hour cough countsdate_rangeTime Frame:At week 2 in period A
- 24 hour cough countsdate_rangeTime Frame:At week 3 in period A
- 24 hour cough countsdate_rangeTime Frame:At week 1 in period B
- 24 hour cough countsdate_rangeTime Frame:At week 2 in period B
- 24 hour cough countsdate_rangeTime Frame:At week 3 in period B
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
7