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

Endometriosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423744
• Other study ID #: 21198
• Secondary ID: 2020-000516-29
• Status: Completed
• Phase: Phase 1
• Start date: June 18, 2020
• Est. completion date: January 21, 2021

Study information

• Verified date: January 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 21, 2021
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Endometriosis
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• BAY1817080
Film-coated tablet
• Moxifloxacin
Film-coated tablet
• Placebo
Matched placebo as film-coated tablet

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Mannheim GmbH	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose		Baseline and Day 3
Primary	Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose		Baseline and Day 3
Secondary	Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin		Baseline and Day 3
Secondary	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		Baseline and Day 3
Secondary	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		Baseline and Day 3
Secondary	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	Predose and up to 24 hours after last dose of BAY1817080 at Day 3
Secondary	AUC after a single oral dose of moxifloxacin	Area under the concentration vs. time curve from zero to infinity after single dose	Predose and up to 24 hours after single dose of moxifloxacin at Day 3
Secondary	Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose	Maximum observed drug concentration in measured matrix after multiple doses	Up to 24 hours after last dose of BAY1817080 at Day 3
Secondary	Cmax after a single oral dose of moxifloxacin	Maximum observed drug concentration in measured matrix after single dose	Up to 24 hours after single dose of moxifloxacin at Day 3
Secondary	Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose		From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days

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