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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423744
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.

Condition or disease Intervention/treatment Phase
Cough Endometriosis Overactive Bladder Drug: BAY1817080 Drug: Moxifloxacin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
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)
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : November 9, 2020
Estimated Study Completion Date : January 27, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention ABCD

Intervention 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

Drug: BAY1817080
Film-coated tablet

Drug: Moxifloxacin
Film-coated tablet

Drug: Placebo
Matched placebo as film-coated tablet

Experimental: Intervention BCDA
Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days
Drug: BAY1817080
Film-coated tablet

Drug: Moxifloxacin
Film-coated tablet

Drug: Placebo
Matched placebo as film-coated tablet

Experimental: Intervention CDAB
Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days
Drug: BAY1817080
Film-coated tablet

Drug: Moxifloxacin
Film-coated tablet

Drug: Placebo
Matched placebo as film-coated tablet

Experimental: Intervention DABC

Subjects 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

Drug: BAY1817080
Film-coated tablet

Drug: Moxifloxacin
Film-coated tablet

Drug: Placebo
Matched placebo as film-coated tablet




Primary Outcome Measures :
  1. 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 ]
  2. Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose [ Time Frame: Baseline and Day 3 ]

Secondary Outcome Measures :
  1. Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and Day 3 ]
  4. AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose [ Time Frame: Predose and up to 24 hours after last dose of BAY1817080 at Day 3 ]
    Area under the concentration vs. time curve from zero to 24 hours after multiple doses

  5. AUC after a single oral dose of moxifloxacin [ Time Frame: Predose and up to 24 hours after single dose of moxifloxacin at Day 3 ]
    Area under the concentration vs. time curve from zero to infinity after single dose

  6. Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose [ Time Frame: Up to 24 hours after last dose of BAY1817080 at Day 3 ]
    Maximum observed drug concentration in measured matrix after multiple doses

  7. Cmax after a single oral dose of moxifloxacin [ Time Frame: Up to 24 hours after single dose of moxifloxacin at Day 3 ]
    Maximum observed drug concentration in measured matrix after single dose

  8. Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose [ Time Frame: From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423744


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Germany
CRS Clinical Research Services Mannheim GmbH Recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04423744    
Other Study ID Numbers: 21198
2020-000516-29 ( EudraCT Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Endometriosis
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents