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

NCT ID: NCT04423744

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2021-01-21

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.

Conditions

Cough; Endometriosis; Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Film-coated tablet

Moxifloxacin

Intervention Type: DRUG

Film-coated tablet

Placebo

Intervention Type: DRUG

Matched placebo as film-coated tablet

Intervention BCDA

Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Film-coated tablet

Moxifloxacin

Intervention Type: DRUG

Film-coated tablet

Placebo

Intervention Type: DRUG

Matched placebo as film-coated tablet

Intervention CDAB

Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Film-coated tablet

Moxifloxacin

Intervention Type: DRUG

Film-coated tablet

Placebo

Intervention Type: DRUG

Matched placebo as film-coated tablet

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

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Film-coated tablet

Moxifloxacin

Intervention Type: DRUG

Film-coated tablet

Placebo

Intervention Type: DRUG

Matched placebo as film-coated tablet

Interventions

BAY1817080

Film-coated tablet

Intervention Type: DRUG

Moxifloxacin

Film-coated tablet

Intervention Type: DRUG

Placebo

Matched placebo as film-coated tablet

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Related Links

https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

2020-000516-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21198

Identifier Type: -

Identifier Source: org_study_id