Single-center, open-label, non-placebo-controlled, single-dose study in healthy male participants to determine the pharmacokinetics of BAY 1817080 oral solution (Part A) and to investigate the pharmacokinetics, metabolic disposition and mass balance of [14C]BAY 1817080 oral solution (Part B)

Completed

Conditions: chronic cough, Endometriosis
chronic cough
Endometriosis

Registration Number: NL-OMON49615

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>• To assess the pharmacokinetics of a single oral dose of BAY 1817080 given as<br /><br>a solution in healthy men.<br /><br><br /><br>Part B<br /><br>• To determine the mass balance and route of excretion, to measure the<br /><br>cumulative amount as well as the time course of drug-related, radiolabeled<br /><br>material excreted in the urine and feces following a single oral dose of<br /><br>[14C]BAY 1817080 given as a solution in healthy men.<br /><br>• To quantify the total radioactivity in blood and plasma.<br /><br>• To quantify unchanged BAY 1817080 in plasma.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Parts A and B<br /><br>• To assess the safety and tolerability of a single oral dose of BAY 1817080<br /><br>(Part A) and [14C]BAY 1817080 (Part B) given as a solution in healthy men.</p><br>