Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1477
Source ID: NCT06487845
Associated Drug: Bay3283142
Title: A Study to Learn How Safe BAY3283142 is When Taken as a Single Dose or as Multiple Doses in Healthy Chinese Participants
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Non-proliferative Diabetic Retinopathy|Healthy Volunteers
Interventions: DRUG: BAY3283142|DRUG: Placebo
Outcome Measures: Primary: Number of participants with treatment emergent adverse event (TEAEs), From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)|Percentage of participants with treatment emergent adverse event (TEAEs), From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days) | Secondary: AUC of BAY3283142, AUC: Area under the concentration vs. Time curve from zero to infinity after single (first) dose, 0 to 48 hours post-dose after the first dose on Day 1|Cmax of BAY3283142, Cmax: Maximum observed drug concentration in measured matrix after single dose administration, directly taken from analytical data, 0 to 48 hours post-dose after the first dose on Day 1|AUC/D of BAY3283142, AUC/D: AUC divided by dose, 0 to 48 hours post-dose after the first dose on Day 1|Cmax/D of BAY3283142, Cmax/D: Cmax devided by dose, 0 to 48 hours post-dose after the first dose on Day 1|AUCτ,md of BAY3283142, AUCτ,md: AUC during any dose interval after multiple dose, 0 to 24 hours post-dose after the last dose on Day 9|Cmax,md of BAY3283142, Cmax,md: Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval, directly taken from analytical data, 0 to 24 hours post-dose after the last dose on Day 9|AUCτ,md/D of BAY3283142, AUCτ,md/D: AUC during any dose interval after multiple dose divided by dose, 0 to 24 hours post-dose after the last dose on Day 9|Cmax,md/D of BAY3283142, Cmax,md/D: Cmax,md divided by dose, 0 to 24 hours post-dose after the last dose on Day 9
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-07-04
Completion Date: 2024-09-19
Results First Posted:
Last Update Posted: 2024-09-24
Locations: The First Affiliated Hospital of Guangzhou University of TCM, Guangzhou, Guangdong, 510405, China
URL: https://clinicaltrials.gov/show/NCT06487845