| Trial ID: | L0734 |
| Source ID: | NCT05800444
|
| Associated Drug: |
Bay3283142
|
| Title: |
A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Healthy Volunteers
|
| Interventions: |
DRUG: BAY3283142|OTHER: Placebo
|
| Outcome Measures: |
Primary: Number of participants with treatment-emergent adverse events (TEAEs), Up to 7 days after end of treatment with study intervention, an average of 18 days | Secondary: Area under the concentration versus time curve from zero to infinity (AUC) after single (first) dose of BAY3283142 on Day 1, 0 to 48 hours post-dose|Maximum observed drug concentration (Cmax) after single (first) dose administration of BAY3283142 on Day 1, 0 to 48 hours post-dose|AUC during any dose interval after (last) multiple doses of BAY3283142 on Day 9 (AUCτ,md), An interval of 24 h will be used for τ (Tau)., 0 to 24 hours post-dose|Maximum observed drug concentration in measured matrix after (last) multiple doses of BAY3283142 on Day 9 (Cmax,md), 0 to 24 hours post-dose
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2023-04-03
|
| Completion Date: |
2023-07-19
|
| Results First Posted: |
|
| Last Update Posted: |
2023-08-21
|
| Locations: |
SOUSEIKAI Fukuoka Mirai Hospital, Fukuoka, 813-0017, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT05800444
|
