Open label, non-randomized, non-placebo controlled Phase 1 study to investigate the mass balance, pharmacokinetics and metabolic disposition of [14C]BAY 3283142 in healthy male participants.

Conditions: chronic kidney disorder
cardiorenal disease
chronic kidney disease
10038430

Registration Number: NL-OMON56921

Lead Sponsor: Bayer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

Participant must be 18 to 55 years of age (both inclusive), at the time of
signing the informed consent. Participants who are overtly healthy as
determined by medical evaluation including medical history, physical
examination, laboratory tests, and cardiac monitoring. Body mass index (BMI)
within the range 18.0 and 29.9 kg/m2 (inclusive). Body weight equal or above 60
kg. Male.

Exclusion Criteria

Pre-existing diseases for which it can be assumed that the absorption,
distribution, metabolism, elimination, and effects of the study interventions
will not be normal. Known or suspected liver disorders (e.g. chronic or acute
hepatitis) or disorders of bile secretion/flow (cholestasis, also history of
it) with the exception of Morbus Meulengracht. Acute diarrhea or constipation
within 14 days before the first intake of study intervention. Regular use of
medicines within the last 14 days before the first study intervention
administration. Participant will be excluded when he participated in another
study with a radiation burden of: greater than 0.1 and less or equal to 1.1 mSv
within 1 year prior to screening; greater than 1.1 and less or equal to 2.1 mSv
within 2 years prior to screening; greater than 2.1 and less or equal to 3.1
mSv within 3 years prior to screening, etc. (add 1 year per 1 mSv).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>%AE,ur(0-tlast) and %AE,fec(0-tlast) (and amount in vomit as a percent of the<br /><br>dose, if applicable) of BAY 3283142 and its metabolites based on radioactivity<br /><br>excreted in urine and feces (as well as vomit, if applicable) as a percent of<br /><br>the dose to assess mass balance of total radioactivity. AUC, Cmax of total<br /><br>radioactivity in plasma and whole blood<br /><br> if AUC cannot be determined reliably in all participants, AUC(0-tlast) will<br /><br>be used instead</p><br>

Secondary Outcome Measures