Clinical trial NCT04423744: 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: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cough
Endometriosis
Overactive Bladder
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose
timeFrame: Baseline and Day 3
measure: Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose
timeFrame: Baseline and Day 3
Secondary outcomes:
measure: Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin
timeFrame: Baseline and Day 3
measure: 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
timeFrame: Baseline and Day 3
measure: 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
timeFrame: Baseline and Day 3
measure: AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
timeFrame: Predose and up to 24 hours after last dose of BAY1817080 at Day 3
measure: AUC after a single oral dose of moxifloxacin
timeFrame: Predose and up to 24 hours after single dose of moxifloxacin at Day 3
measure: Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
timeFrame: Up to 24 hours after last dose of BAY1817080 at Day 3
measure: Cmax after a single oral dose of moxifloxacin
timeFrame: Up to 24 hours after single dose of moxifloxacin at Day 3
measure: Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose
timeFrame: From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
state: Baden-Württemberg
Study officials:
References: