A Study to Learn How Safe BAY3283142 is When Taken as a Single Dose or as Multiple Doses in Healthy Chinese Participants

Phase 1

Active, not recruiting

• Conditions: Chronic Kidney Disease; Non-proliferative Diabetic Retinopathy; Healthy Volunteers

• Registration Number: NCT06487845
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Inclusion Criteria:<br><br> - Participants must be 18 to 45 years of age (both inclusive) at the time of signing<br> the informed consent.<br><br> - Participants who are overtly healthy as determined by medical evaluation including<br> medical history, physical examination, laboratory test and 12-lead ECG.<br><br> - Race: Chinese<br><br> - Body mass index (BMI) within the range 18.0 - 27.9 kg/m² (both inclusive) at<br> screening.<br><br> - Body weight of at least 55 kg at screening.<br><br> - Male and female, female only allowed in the 5 mg dose group. Contraceptive use by<br> men and women should be consistent with local regulations regarding the methods of<br> contraception for those participating in clinical studies.<br><br>Exclusion Criteria:<br><br> - Known tendency for vasovagal reactions (e.g., after venipuncture) or history of<br> syncope.<br><br> - Systolic blood pressure below 100 mmHg or above 140 mmHg (after 15 minutes of supine<br> rest) at screening.<br><br> - Diastolic blood pressure below 60 mmHg or above 90 mmHg (after 15 minutes of supine<br> rest) at screening.<br><br> - Heart rate below 50 or above 90 beats per minute (after 15 minutes of supine rest)<br> at screening.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse event (TEAEs);Percentage of participants with treatment emergent adverse event (TEAEs)

Secondary Outcome Measures

Name	Time	Method
AUC of BAY3283142;Cmax of BAY3283142;AUC/D of BAY3283142;Cmax/D of BAY3283142;AUCt,md of BAY3283142;Cmax,md of BAY3283142;AUCt,md/D of BAY3283142;Cmax,md/D of BAY3283142