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CoughPhase 1/2NCT03535168

Repeat Doses of BAY1902607 in Healthy Males and Proof of Concept in Chronic Cough Patients

A Phase 1/2 study testing BAY1902607 and Midazolam in people with Cough, run by Bayer at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cough
What is being tested?
BAY1902607 and Midazolam
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
8 sitesin 2 countries
Study dates
29 May 2018to 11 Oct 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, heart rate), 12-lead ECG, clinical laboratory tests
  • Age: 18-45 years (inclusive) at the first screening visit
  • Non-smoker for at least 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, 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:
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  • Age: ≥18 years at the first screening visit
  • Refractory chronic cough for at least one year that has been shown to be unresponsive to treatment of cough according to the 2006 British Thoracic Society (BTS) guideline
  • Score of ≥ 40 mm on the Cough Severity visual analogue scale (VAS) at screening
  • 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 31 days (1 average menstrual cycle of 28 days plus approx. 5 half-lives of BAY 1902607) after the last dose. In addition during the study and for at least 31 days after the last dose women of child bearing potential are not allowed to donate oocytes.

Who cannot join

  • Part 1:
  • Relevant diseases potentially interfering with the study objectives (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 ability to taste, as revealed by the taste-disturbance questionnaire during screening and the predose procedures
  • Part 2:
  • FEV1(Forced Expiratory Volume in 1 second) or FVC(Forced Vital Capacity ) of less than 60% of predicted normal, at screening
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  • History of upper or lower respiratory tract infection or recent significant change in pulmonary status within the 4 weeks before screening
  • 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

8 sites in 2 countries.

8 sites in 2 countries

United Kingdom6 sites

  • Queen's University

    Belfast, Antrim, BT9 7BL

  • Birmingham Heartlands Hospital

    Birmingham, West Midlands, B9 5SS

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • King's College Hospital - NHS Foundation Trust

    London, SE5 9RS

  • Medicines Evaluation Unit

    Manchester, M23 9GP

  • University Hospital of South Manchester

    Manchester, M23 9LT

Other trials in United Kingdom

Netherlands2 sites

  • Catharina Ziekenhuis

    Eindhoven, North Brabant, 5623 EJ

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

Official title: 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

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).
Conditions
Cough
Being tested
BAY1902607, Matching placebo, Midazolam
Keywords
Healthy volunteers
Medical subject headings
Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1902607Drug

    3 different doses over the course of part 1 and 4 different doses over the course of part 2.

  • Matching placeboDrug

    Matching placebo for BAY1902607

  • MidazolamDrug

    Part 1: The subjects will initially (Day -1) receive a sub-therapeutic dose of 1 mg midazolam as solution in the morning.

Study groups in NCT03535168
Study groupRoleWhat they receive
Dose 1 of BAY1902607ExperimentalPart 1: From Day 1 until Day 12 the dose 1 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 1 of BAY1902607 will be given only once.
Receives: Drug: BAY1902607; Drug: Midazolam
Dose 2 of BAY1902607ExperimentalPart 1: From Day 1 until Day 12 the dose 2 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 2 of BAY1902607 will be given only once.
Receives: Drug: BAY1902607; Drug: Midazolam
Dose 3 of BAY1902607ExperimentalPart 1: From Day 1 until Day 12 the dose 3 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 3 of BAY1902607 will be given only once.
Receives: Drug: BAY1902607; Drug: Midazolam
Matching placeboExperimentalPart 1: From Day 1 until Day 12 the matching placebo will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, matching placebo will be given only once.
Receives: Drug: Matching placebo; Drug: Midazolam
BAY1902607+Matching PlaceboExperimentalPart 2: Randomized crossover design in cough patients 4 different doses of BAY1902607+matching placebo
Receives: Drug: BAY1902607; Drug: Matching placebo
Matching Placebo+BAY1902607ExperimentalPart 2: Randomized crossover design in cough patients Matching placebo+4 different doses of BAY1902607
Receives: Drug: BAY1902607; Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 1

    Measured: Approximately 5 weeks

  2. Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 2

    Measured: Approximately 12 weeks

  3. AUC of midazolam without BAY1902607

    Part 1

    Measured: At Day -1

  4. AUC of midazolam in combination with BAY1902607

    Part 1

    Measured: At Day 13

  5. Cmax of midazolam in combination with BAY1902607

    Part 1

    Measured: At Day 13

  6. Cmax of midazolam without BAY1902607

    Part 1

    Measured: At Day -1

  7. 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)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study start29 May 2018
  3. Primary completion25 Sep 2019
  4. Study completion11 Oct 2019

Resources

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: Sequential parallel-group Part 2: Two-arm crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03535168
Sponsor's protocol ID
19430
Other IDs
2018-000129-29, 2018
Status last verified
Feb 2021
First submitted
14 May 2018
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

Publications

  • Friedrich C, Francke K, Birring SS, van den Berg JWK, Marsden PA, McGarvey L, Turner AM, Wielders P, Gashaw I, Klein S, Morice AH. The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial. Respir Res. 2023 Apr 11;24(1):109. doi: 10.1186/s12931-023-02384-8.

    PubMed 37041539

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BAY1902607 and Midazolam in people with Cough, run by Bayer at 8 sites in 2 countries.

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 11 inclusion and 9 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom, Netherlands. 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. 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?

Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 1 (time frame: Approximately 5 weeks). The study lists 7 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 NCT03535168, which also lists 1 linked publication.

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 10 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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