Status:
COMPLETED
A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)
Lead Sponsor:
Bayer
Conditions:
Endometriosis Related Pain
Overactive Bladder
Eligibility:
MALE
18-54 years
Phase:
PHASE1
Brief Summary
Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar ...
Eligibility Criteria
Inclusion
- Capable of giving signed informed consent as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
- Ability to understand and follow study-related instructions;
- Participant has signed the ICF before any study specific tests or procedures are done;
- Healthy male participant;
- Age: 18 to 54 years (inclusive) at the time of informed consent and first dose of study medication;
- Body mass index (BMI) ≥18 and ≤30 kg/m\^2 at Screening;
- Body weight of at least 45 kg at Screening;
- Participant agrees to use contraception as described in Appendix.
Exclusion
- Presence or history of clinically relevant cardiovascular, central nervous system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash;
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations);
- Known severe allergies, e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract (e.g., allergic asthma), allergies requiring therapy with corticosteroids or significant nonallergic drug reactions;
- Febrile illness within 1 week before study drug administration;
- Current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent occurrence of heartburn \[more than once per week\], or any gastrointestinal surgical intervention \[e.g. cholecystectomy\]);
- Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Screening;
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of study intervention will not be normal;
- Poor peripheral venous access;
- Regular use of medicines within 14 days prior to administration of study intervention;
- Regular use of therapeutic or recreational drugs, e.g., cannabis, carnitine products, anabolics, high dose vitamins within 3 months prior to screening;
- Any use of medicines or substances within 14 days prior to administration, which oppose the study objectives or might affect the PK of BAY1817080 (e.g., laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, systemic antibiotics, CYP3A4 inducers, CYP3A4 inhibitors, "organic anion transporting polypeptide" (OATP) / "breast cancer resistance protein" (BCRP) substrates, P-gp substrates and inhibitors). Relevant medication of individual participants will be discussed with the study medical expert before first dosing in the study.
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04487431
Start Date
August 5 2020
End Date
February 11 2021
Last Update
January 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PRAHealthSciences
Groningen, Netherlands, 9728 NZ