Status:
COMPLETED
A Trial to Learn What Happens to Different Medicinal Forms of BAY2328065 When They Enter the Body and How Safe They Are in Healthy Male and Female Participants
Lead Sponsor:
Bayer
Conditions:
Endometriosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Researchers are looking for a different way to treat women with a condition in which tissue that normally lines the uterus grows outside the uterus. This condition is called endometriosis. Before a tr...
Eligibility Criteria
Inclusion
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
- Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, blood pressure and heart rate
- Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
- Body mass index (BMI) within the range 18 and 30 kg/m\^2 (inclusive)
- Male participants who are sexually active and female participants of childbearing potential must use one of the methods of contraception described in this protocol
Exclusion
- Incompletely cured 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
- Relevant diseases within the last 4 weeks prior to start of the first study intervention
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Existing chronic diseases as specified in protocol
- Regular use of therapeutic or recreational drugs
- Suspicion of drug or alcohol abuse
- Smoking equal or more than 10 cigarettes/day
- History of COVID-19; contact with SARS-CoV-2 positive persons or COVID-19 patients within the last 4 weeks prior admission to the ward or positive SARS-CoV-2 viral RNA test
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04851483
Start Date
April 28 2021
End Date
February 14 2022
Last Update
June 1 2022
Active Locations (1)
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1
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167