chronic cough, Endometriosis chronic cough Endometriosis
Conditions
Interventions
Part A:
Day Description
-1 Entry in the research center
1 Administration of 50 mg BAY 1817080 and other procedures (see below)
2 and 3 Stay in the research center for blood samples and health checks
4
Sponsors
Bayer AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent as described in Appendix 10.1.4, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol; 2. Ability to understand and follow study-related instructions; 3. Participant has signed the ICF before any study specific tests or procedures are done; 4. Healthy male participant; 5. Age: 18 to 65 years (inclusive) at the time of informed consent and first dose of study medication For the complete overview see the protocol
Exclusion criteria
Exclusion criteria: 1. 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; 2. Known hypersensitivity to the study drugs (active substances or excipients of the preparations); 3. 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 non-allergic drug reactions; 4. Febrile illness within 1 week before study drug administration; 5. 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]); For the complete overview see the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A • To assess the pharmacokinetics of a single oral dose of BAY 1817080 given as a solution in healthy men. Part B • To determine the mass balance and route of excretion, to measure the cumulative amount as well as the time course of drug-related, radiolabeled material excreted in the urine and feces following a single oral dose of [14C]BAY 1817080 given as a solution in healthy men. • To quantify the total radioactivity in blood and plasma. • To quantify unchanged BAY 1817080 in plasma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Parts A and B • To assess the safety and tolerability of a single oral dose of BAY 1817080 (Part A) and [14C]BAY 1817080 (Part B) given as a solution in healthy men. | — |
Countries
Netherlands
Outcome results
None listed