| Trial ID: | L0303 |
| Source ID: | NCT04820621
|
| Associated Drug: |
Runcaciguat (Bay1101042)
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| Title: |
Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Runcaciguat (BAY1101042)
|
| Outcome Measures: |
Primary: Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042, AUC(0-tlast) will be used as main parameters if mean AUC(tlast - ∞) \>20% of AUC, From dosing day (Day 1) up to 12 days post dose|Unbound AUC (AUCu) of BAY1001042, AUC(0-tlast)u will be used as main parameters if mean AUC(tlast - ∞) \>20% of AUC, From dosing day (Day 1) up to 12 days post dose|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1001042, From dosing day (Day 1) up to 12 days post dose|Unbound Cmax (Cmax,u) of BAY1001042, From dosing day (Day 1) up to 12 days post dose | Secondary: Numbers of participants with treatment-emergent adverse events (TEAEs) and study intervention related TEAE, From start of treatment up to 10 days after the treatment
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
5
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-04-07
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| Completion Date: |
2021-07-01
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| Results First Posted: |
|
| Last Update Posted: |
2021-07-15
|
| Locations: |
CRS Clinical-Research-Services Kiel GmbH, Kiel, Schleswig-Holstein, 24105, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT04820621
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