To determine the mass balance and routes of excretion of total radioactivity after a single oral 10 mg dose of [14C]BAY 3283142 given as a solution. To quantify total radioactivity in plasma and whole blood
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
Synonym
Health condition
chronic kidney disorder
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
%AE,ur(0-tlast) and %AE,fec(0-tlast) (and amount in vomit as a percent of the
dose, if applicable) of BAY 3283142 and its metabolites based on radioactivity
excreted in urine and feces (as well as vomit, if applicable) as a percent of
the dose to assess mass balance of total radioactivity. AUC*, Cmax of total
radioactivity in plasma and whole blood
* if AUC cannot be determined reliably in all participants, AUC(0-tlast) will
be used instead
Secondary outcome
Number of participants who experienced serious or non-serious TEAEs after
administration of BAY 3283142
Background summary
sGC activators directly stimulate sGC to produce cGMP even under conditions of
high oxidative stress, that lead to loss of the enzyme*s heme group and render
it non-responsive towards stimulation with NO. NO deficiency, reduced sGC
activity, and reduced cGMP levels have been implicated in the pathology and
progression of CKD.
It is anticipated that direct activation of sGC by BAY 3283142 under conditions
of oxidative stress that are prevailing in CKD will reduce cardiovascular
mortality and progression of kidney disease in patients suffering from CKD by
reducing intraglomerular filtration pressure, albuminuria, and kidney fibrosis.
plaese see section 2.2 "background" of the clinical study protocol
Study objective
To determine the mass balance and routes of excretion of total radioactivity
after a single oral 10 mg dose of [14C]BAY 3283142 given as a solution. To
quantify total radioactivity in plasma and whole blood
Study design
single center, open label, non-randomized, non-placebo controlled, mass balance
study.
Intervention
NA
Study burden and risks
please see section 2.3. "benefit/risk assessment" of the clinical study
protocol version
Siriusdreef 36
Hoofddorp 2132 WT
NL
Siriusdreef 36
Hoofddorp 2132 WT
NL
Listed location countries
Age
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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 2024-510765-42-00 |
| CCMO | NL86843.056.24 |