| Trial ID: | L1193 |
| Source ID: | NCT05515432
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| Associated Drug: |
Single Oral Dose Of Bay3283142 Ir (Immediate Release) Tablet
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| Title: |
A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Chronic Kidney Disease|Renal Impairment|Healthy Volunteers
|
| Interventions: |
DRUG: Single oral dose of BAY3283142 IR (immediate release) tablet
|
| Outcome Measures: |
Primary: AUC of BAY3283142, AUC(0-tlast) will be used as main parameters if AUC cannot be reliably determined in all participants, up to 0 - 96 hours post-dose|AUCu of BAY3283142, AUC(0-tlast)u will be used as main parameters if AUC cannot be reliably determined in all participants, up to 0 - 96 hours post-dose|Cmax of BAY3283142, up to 0 - 96 hours post-dose|Cmax,u of BAY3283142, up to 0 - 96 hours post-dose | Secondary: Number of participants with treatment-emergent adverse events (TEAEs) after intake of BAY3283142, up to 7 days post-dose
|
| Sponsor/Collaborators: |
Sponsor: Bayer
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
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| Enrollment: |
45
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2022-08-11
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| Completion Date: |
2023-06-06
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| Results First Posted: |
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| Last Update Posted: |
2023-08-21
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| Locations: |
CRS Clinical-Research-Services Kiel GmbH, Kiel, Schleswig-Holstein, 24105, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT05515432
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