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CoughPhase 1NCT04423744

Study to Gather Information on the Influence of BAY1817080 on the Electrical Activity of the Heart Recorded by an Electrocardiogram in Healthy Male and Female Participants

A Phase 1 study testing BAY1817080 and Moxifloxacin in people with Cough and Endometriosis, run by Bayer at 1 site in Germany.

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

In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cough, Endometriosis, Overactive Bladder
What is being tested?
BAY1817080 and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteGermany
Study dates
18 Jun 2020to 21 Jan 2021
Phase
Phase 1
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men must be 18 to 65 years of age inclusive, women must be 40 to 65 years of age inclusive at the time of signing the informed consent
  • Female participants have to be in postmenopausal state
  • Body mass index (BMI) within the range 18.0-32.0 kg/m^2 (inclusive)
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, and vital signs
  • 12-lead electrocardiogram recording without signs of clinically relevant pathology

Who cannot join

  • A history of relevant diseases of vital organs, of the central nervous system or other organs
  • Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal
  • Known hypersensitivity to the study interventions (active substances, or excipients of the preparations)
  • Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant nonallergic drug reactions
  • Febrile illness within 1 week before study intervention administration
  • Known or suspected disorder of the liver (e.g. bile secretion/flow disorder, Morbus Meulengracht (Gilbert´s syndrome), drug-induced hepatitis etc.)
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  • History of disorder of the pancreas or evidence for past or present pancreas disorders indicated by clinically relevant lipase or amylase levels above ULN and typical clinical symptoms of pancreas disorders as e.g. upper abdominal pain spread to the back, weight loss, fatty or pale stools
  • Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening (inclusion with normal fT3/fT4 levels allowed)
  • History of known or suspected malignant tumors
  • History of hypokalemia
  • Use of CYP3A4 inhibitors from 14 days before study intervention administration until the last study visit
  • Use of CYP3A4 inducers within 4 weeks (or at least five half-lives of the active substance whatever is longer) prior to study intervention administration
  • Smoking more than 10 cigarettes daily
  • Suspicion of drug or alcohol abuse
  • Plasmapheresis within 3 months prior to study drug administration
  • Excluded physical therapies that might alter the PK or safety results of the study (e.g. physiotherapy, acupuncture, etc.) from 7 days before first study drug administration until follow-up
  • Systolic blood pressure below 100 mmHg or above 140 mmHg at screening. Difference of systolic BP between both arms >15 mmHg
  • Diastolic blood pressure below 50 mmHg or above 90 mmHg at screening
  • Heart rate below 50 beats/ min or above 90 beats/ min at screening
  • History of COVID-19
  • Prior contact with SARS-CoV-2 positive or COVID-19 patient within the last 4 weeks prior admission to the ward
  • Positive SARS-CoV-2 viral test

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical Research Services Mannheim GmbH

    Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

About this study

Official title: Randomized, Single-blind, Double-dummy, 4-fold Cross-over, Placebo- and Active-controlled Study to Investigate the Influence of BAY 1817080 on the QTc Interval in Healthy Male and Female Participants (TQT Study)

In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.

Being tested
BAY1817080, Moxifloxacin, Placebo
Medical subject headings
Cough, Endometriosis, Urinary Bladder, Overactive

What participants receive

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

  • BAY1817080Drug

    Film-coated tablet

  • MoxifloxacinDrug

    Film-coated tablet

  • PlaceboDrug

    Matched placebo as film-coated tablet

Study groups in NCT04423744
Study groupRoleWhat they receive
Intervention ABCDExperimentalIntervention A: Day 1 and 2: Supra-therapeutic dose of BAY1817080, three times daily (tid) Day 3: Supra-therapeutic dose of BAY1817080 and placebo to moxifloxacin, once Intervention B: Day 1 and 2: therapeutic dose of BAY1817080 and placebo to BAY1817080, tid Day 3: therapeutic dose of BAY1817080, placebo to BAY1817080 and placebo to moxifloxacin, once Intervention C: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and moxifloxacin, once Intervention D: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and placebo to moxifloxacin, once Subjects will receive intervention A, B, C and D sequentially. The washing-out period between each intervention is at least 14 days
Receives: Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo
Intervention BCDAExperimentalSubjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days
Receives: Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo
Intervention CDABExperimentalSubjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days
Receives: Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo
Intervention DABCExperimentalSubjects will receive intervention D, A, B and C sequentially. The washing-out period between each intervention is at least 14 days Note: the intervention sequences in this and above arms are examples, the actual order of intervention may differ from these examples
Receives: Drug: BAY1817080; Drug: Moxifloxacin; Drug: Placebo

What is being measured

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

  1. Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose

    Measured: Baseline and Day 3

  2. Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose

    Measured: Baseline and Day 3

Secondary outcomes (8)

  1. Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin

    Measured: Baseline and Day 3

  2. Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose

    Measured: Baseline and Day 3

  3. Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after a single oral dose of moxifloxacin

    Measured: Baseline and Day 3

  4. AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose

    Area under the concentration vs. time curve from zero to 24 hours after multiple doses

    Measured: Predose and up to 24 hours after last dose of BAY1817080 at Day 3

  5. AUC after a single oral dose of moxifloxacin

    Area under the concentration vs. time curve from zero to infinity after single dose

    Measured: Predose and up to 24 hours after single dose of moxifloxacin at Day 3

  6. Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose

    Maximum observed drug concentration in measured matrix after multiple doses

    Measured: Up to 24 hours after last dose of BAY1817080 at Day 3

  7. Cmax after a single oral dose of moxifloxacin

    Maximum observed drug concentration in measured matrix after single dose

    Measured: Up to 24 hours after single dose of moxifloxacin at Day 3

  8. Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose

    Measured: From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days

Timeline

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

  1. First posted9 Jun 2020
  2. Study start18 Jun 2020
  3. Primary completion9 Nov 2020
  4. Study completion21 Jan 2021

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04423744
Sponsor's protocol ID
21198
Other IDs
2020-000516-29
Status last verified
Jan 2022
First submitted
8 Jun 2020
Last updated
24 Jan 2022
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1817080 and Moxifloxacin in people with Cough and Endometriosis, run by Bayer at 1 site in Germany.

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 5 inclusion and 22 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 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.

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?

Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose (time frame: Baseline and Day 3). The study lists 2 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 NCT04423744.

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 24 Jan 2022.

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