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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

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ClinicalTrials.gov Identifier: NCT04423744
Recruitment Status : Active, not recruiting
First Posted : June 9, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE June 8, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE June 18, 2020
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
  • 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
  • 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
  • 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
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Cough
  • Endometriosis
  • Overactive Bladder
Intervention  ICMJE
  • Drug: BAY1817080
    Film-coated tablet
  • Drug: Moxifloxacin
    Film-coated tablet
  • Drug: Placebo
    Matched placebo as film-coated tablet
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: BAY1817080
    • Drug: Moxifloxacin
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: BAY1817080
    • Drug: Moxifloxacin
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: BAY1817080
    • Drug: Moxifloxacin
    • Drug: Placebo
  • 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

    Interventions:
    • Drug: BAY1817080
    • Drug: Moxifloxacin
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 2, 2020)
38
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2020)
40
Estimated Study Completion Date  ICMJE January 27, 2021
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04423744
Other Study ID Numbers  ICMJE 21198
2020-000516-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bayer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP