check_circleStudy Completed

Cough

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).

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
87
Trial Dates
December 2017 - June 2019
Phase
Phase 1/Phase 2
Could I Receive a placebo
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medicines Evaluation UnitManchester, M23 9QZ, United Kingdom
Completed
Castle Hill HospitalCottingham, HU16 5JQ, United Kingdom
Completed
University Hospital of South ManchesterManchester, M23 9LT, United Kingdom
Completed
King's College Hospital - NHS Foundation TrustLondon, SE5 9RS, United Kingdom
Completed
North Tyneside General HospitalNorth Shields, NE29 8NH, United Kingdom
Completed
Queen's UniversityBelfast, BT9 7AB, United Kingdom
Completed
Birmingham Heartlands HospitalBirmingham, B9 5SS, United Kingdom

Primary Outcome

  • Frequency of treatment emergent adverse events in study part 1
    date_rangeTime Frame:
    Up to 5 weeks
  • Severity of treatment emergent adverse events in study 1
    The 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 status
    date_rangeTime Frame:
    Up to 5 weeks
  • Frequency of treatment emergent adverse events in study part 2
    date_rangeTime Frame:
    Up to 12 weeks
  • Severity of treatment emergent adverse events in study part 2
    The 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 status
    date_rangeTime Frame:
    Up to 12 weeks
  • 24-hour cough counts
    date_rangeTime Frame:
    At week 1 in period A
  • 24 hour cough counts
    date_rangeTime Frame:
    At week 2 in period A
  • 24 hour cough counts
    date_rangeTime Frame:
    At week 3 in period A
  • 24 hour cough counts
    date_rangeTime Frame:
    At week 1 in period B
  • 24 hour cough counts
    date_rangeTime Frame:
    At week 2 in period B
  • 24 hour cough counts
    date_rangeTime Frame:
    At week 3 in period B

Trial design

Two-part, double-blind, placebo-controlled, randomized, parallel-group study: (Part 1) in healthy male volunteers to assess safety and tolerability of ascending repeated oral doses of BAY1817080, followed by (Part 2), two-way crossover administration of four different doses 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
7