CoughPhase 1/2NCT03310645
Repeat Doses of BAY 1817080 in Healthy Males & Proof of Concept in Chronic Cough Patients
A Phase 1/2 study testing BAY1817080 in people with Cough, run by Bayer at 7 sites in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough
- What is being tested?
- BAY1817080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 7 Dec 2017to 19 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1
- Male; healthy according to complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12 lead ECG, clinical laboratory tests
- Age: 18-45 years (inclusive) at the first screening visit.
- Non-smoker for at least the past 6 months and with a pack year history of equal to or less than 5 years.
- Subjects who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously when having sexual intercourse with women of childbearing potential (one method used by the subject and one method used by the partner) during the study and for 90 days after receiving the investigational medicinal product and not to act as sperm donor for 90 days after dosing. [Acceptable methods of contraception include for example: (a) condoms (male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with spermicide, (c) intrauterine device, (d) hormone-based contraception.
- Part 2:
Show all 14Show fewer
- Age: >18 years at the first screening visit
- Refractory chronic cough for at least one year:
- that has been shown to be unresponsive to at least 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip or unexplained cough, and
- for which no objective evidence of an underlying trigger can be determined after investigation.
- Score of >40 mm on the Cough Severity visual analogue scale (VAS) at screening.
- For male patients:
- Male patients who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for 90 days after receiving the investigational medicinal product and not to act as sperm donor for 90 days after dosing. [Acceptable methods of contraception include for example: (a) condoms (male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with spermicide, (c) intrauterine device, (d) hormone-based contraception.
- --For female patients: Confirmed post-menopausal woman (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL) or Woman without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification) or Woman of childbearing potential that agrees to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for at least 10 days after the last dose. Acceptable methods of contraception include for example: (a)condoms (male or female) with or without a spermicidal agent (b)diaphragm or cervical cap with spermicide (c) intrauterine device (d)hormone-based contraception.
Who cannot join
- Part 1
- Relevant diseases potentially interfering with the study's aims (e.g.respiratory diseases) within the four weeks before screening or between screening and randomization
- Any febrile illness within the four weeks before screening or between screening and randomization
- Medical history of hypogeusia/dysgeusia or the subject has a dysfunction in his/her ability to taste, as revealed by the taste disturbance questionnaire during screening and the pre dose procedures
- Use of any over-the-counter cough mixture within the 24 hours before screening
- Part 2:
Show all 10Show fewer
- FEV1 or FVC of less than 60% of predicted normal, at screening
- History of upper or lower respiratory tract infection or recent significant change in pulmonary status within the 4 weeks before baseline visit.
- Current smoking habit or history of smoking within the 6 months before the screening visit.
- History of smoking (at any time) for more than 20 pack-years in total (20 cigarettes per pack)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Queen's University
Belfast, BT9 7AB
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS
Castle Hill Hospital
Cottingham, HU16 5JQ
King's College Hospital - NHS Foundation Trust
London, SE5 9RS
University Hospital of South Manchester
Manchester, M23 9LT
Medicines Evaluation Unit
Manchester, M23 9QZ
North Tyneside General Hospital
North Shields, Tyne and Wear, NE29 8NH
About this study
Official title: 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
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).
- Conditions
- Cough
- Being tested
- BAY1817080, Matching Placebo
- Keywords
- Refractory chronic cough, healthy volunteers
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1817080Drug
4 different doses over the course of study
Matching PlaceboDrug
Matching placebo for BAY1817080
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of BAY1817080 | Experimental | Study Part 1:
Oral dose 1 of BAY1817080 twice daily with a loading dose administered three times on Day 1 Receives: Drug: BAY1817080 |
| Dose 2 of BAY1817080 | Experimental | Study Part 1:
Oral dose 2 of BAY1817080 twice daily with a loading dose administered three times on Day 1 Receives: Drug: BAY1817080 |
| Dose 3 of BAY1817080 | Experimental | Study Part 1:
Oral dose 3 of BAY1817080 twice daily with a loading dose administered three times on Day 1 Receives: Drug: BAY1817080 |
| Dose 4 of BAY1817080 | Experimental | Study Part 1:
Oral dose 4 of BAY1817080 twice daily with a loading dose administered three times on Day 1 Receives: Drug: BAY1817080 |
| Placebo | Placebo comparator | Study Part 1:
Oral dose of matching placebo twice daily with a loading dose administered three times on Day 1 Receives: Drug: Matching Placebo |
| Placebo+BAY1817080 | Experimental | Study Part 2:
Randomized crossover design in cough patients Placebo+4 different doses of BAY1817080 Receives: Drug: BAY1817080; Drug: Matching Placebo |
| BAY1817080+Placebo | Experimental | Study Part 2:
Randomized crossover design in cough patients 4 different doses of BAY1817080+Placebo Receives: Drug: BAY1817080; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment emergent adverse events in study part 1
Measured: 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
Measured: Up to 5 weeks
Frequency of treatment emergent adverse events in study part 2
Measured: 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
Measured: Up to 12 weeks
24-hour cough counts
Measured: At week 1 in period A
24 hour cough counts
Measured: At week 2 in period A
24 hour cough counts
Measured: At week 3 in period A
24 hour cough counts
Measured: At week 1 in period B
24 hour cough counts
Measured: At week 2 in period B
24 hour cough counts
Measured: At week 3 in period B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start7 Dec 2017
- Primary completion28 May 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: Ascending multiple doses in healthy volunteers Part 2: Ascending doses within two-way crossover design in patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310645
- Sponsor's protocol ID
- 18184
- Other IDs
- 2017-001620-22, 2017
- Status last verified
- Jan 2023
- First submitted
- 28 Sep 2017
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Reif S, Schultze-Mosgau MH, Engelen A, Piel I, Denner K, Roffel A, Tiessen R, Klein S, Francke K, Rottmann A. Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers. Eur J Drug Metab Pharmacokinet. 2024 Jan;49(1):71-85. doi: 10.1007/s13318-023-00866-0. Epub 2023 Dec 3.
PubMed 38044419Friedrich C, Francke K, Gashaw I, Scheerans C, Klein S, Fels L, Smith JA, Hummel T, Morice A. Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study. Clin Pharmacokinet. 2022 Aug;61(8):1143-1156. doi: 10.1007/s40262-022-01126-1. Epub 2022 May 28.
PubMed 35624408Morice A, Smith JA, McGarvey L, Birring SS, Parker SM, Turner A, Hummel T, Gashaw I, Fels L, Klein S, Francke K, Friedrich C. Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study. Eur Respir J. 2021 Nov 18;58(5):2004240. doi: 10.1183/13993003.04240-2020. Print 2021 Nov.
PubMed 33986030
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03310645
- Acronym / sponsor ID
- 18184
- Conditions
- Cough
- Keywords
- Refractory chronic cough, healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Part 1: Ascending multiple doses in healthy volunteers Part 2: Ascending doses within two-way crossover design in patients
| Arm | Type | Receives |
|---|---|---|
| Dose 1 of BAY1817080 | Experimental | Drug: BAY1817080Study Part 1: Oral dose 1 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Dose 2 of BAY1817080 | Experimental | Drug: BAY1817080Study Part 1: Oral dose 2 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Dose 3 of BAY1817080 | Experimental | Drug: BAY1817080Study Part 1: Oral dose 3 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Dose 4 of BAY1817080 | Experimental | Drug: BAY1817080Study Part 1: Oral dose 4 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Placebo | Placebo comparator | Drug: Matching PlaceboStudy Part 1: Oral dose of matching placebo twice daily with a loading dose administered three times on Day 1 |
| Placebo+BAY1817080 | Experimental | Drug: BAY1817080, Drug: Matching PlaceboStudy Part 2: Randomized crossover design in cough patients Placebo+4 different doses of BAY1817080 |
| BAY1817080+Placebo | Experimental | Drug: BAY1817080, Drug: Matching PlaceboStudy Part 2: Randomized crossover design in cough patients 4 different doses of BAY1817080+Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Part 1
- Male; healthy according to complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12 lead ECG, clinical laboratory tests
- Age: 18-45 years (inclusive) at the first screening visit.
- Non-smoker for at least the past 6 months and with a pack year history of equal to or less than 5 years.
- Subjects who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously when having sexual intercourse with women of childbearing potential (one method used by the subject and one method used by the partner) during the study and for 90 days after receiving the investigational medicinal product and not to act as sperm donor for 90 days after dosing. [Acceptable methods of contraception include for example: (a) condoms (male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with spermicide, (c) intrauterine device, (d) hormone-based contraception.
Key exclusion criteria (10 listed)
- Part 1
- Relevant diseases potentially interfering with the study's aims (e.g.respiratory diseases) within the four weeks before screening or between screening and randomization
- Any febrile illness within the four weeks before screening or between screening and randomization
- Medical history of hypogeusia/dysgeusia or the subject has a dysfunction in his/her ability to taste, as revealed by the taste disturbance questionnaire during screening and the pre dose procedures
- Use of any over-the-counter cough mixture within the 24 hours before screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY18170804 different doses over the course of study | Drug | BAY1817080+Placebo, Dose 1 of BAY1817080, Dose 2 of BAY1817080, Dose 3 of BAY1817080, Dose 4 of BAY1817080, Placebo+BAY1817080 |
| Matching PlaceboMatching placebo for BAY1817080 | Drug | BAY1817080+Placebo, Placebo, Placebo+BAY1817080 |
Primary outcome
Frequency of treatment emergent adverse events in study part 1
Time frame: Up to 5 weeks
Severity of treatment emergent adverse events in study 1
Time frame: Up to 5 weeks
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
Frequency of treatment emergent adverse events in study part 2
Time frame: Up to 12 weeks
Severity of treatment emergent adverse events in study part 2
Time frame: Up to 12 weeks
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
24-hour cough counts
Time frame: At week 1 in period A
24 hour cough counts
Time frame: At week 2 in period A
24 hour cough counts
Time frame: At week 3 in period A
24 hour cough counts
Time frame: At week 1 in period B
24 hour cough counts
Time frame: At week 2 in period B
24 hour cough counts
Time frame: At week 3 in period B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 38044419Reif S, Schultze-Mosgau MH, Engelen A, Piel I, Denner K, Roffel A, Tiessen R, Klein S, Francke K, Rottmann A. Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers. Eur J Drug Metab Pharmacokinet. 2024 Jan;49(1):71-85. doi: 10.1007/s13318-023-00866-0. Epub 2023 Dec 3.
- Derived from this study: PubMed 35624408Friedrich C, Francke K, Gashaw I, Scheerans C, Klein S, Fels L, Smith JA, Hummel T, Morice A. Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study. Clin Pharmacokinet. 2022 Aug;61(8):1143-1156. doi: 10.1007/s40262-022-01126-1. Epub 2022 May 28.
- Derived from this study: PubMed 33986030Morice A, Smith JA, McGarvey L, Birring SS, Parker SM, Turner A, Hummel T, Gashaw I, Fels L, Klein S, Francke K, Friedrich C. Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study. Eur Respir J. 2021 Nov 18;58(5):2004240. doi: 10.1183/13993003.04240-2020. Print 2021 Nov.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Cough
RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
Cough
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Recruiting
Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer
Head and Neck Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BAY1817080 in people with Cough, run by Bayer at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment emergent adverse events in study part 1 (time frame: Up to 5 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310645, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.