Trial Condition(s):

Cough, Endometriosis, Overactive Bladder

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

Bayer Identifier:

21198

ClinicalTrials.gov Identifier:

NCT04423744

EudraCT Number:

2020-000516-29

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
42
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Mannheim GmbH

Mannheim, Germany, 68167

Status
Completed
 

Trial Design