Single center, open-label, non-randomized, non-placebo-controlled study to investigate the pharmacokinetics, metabolic disposition and mass balance after single administration of 5 mg [14C]BAY 1021189 (oral solution) in healthy male subjects

Completed

• Conditions: Cardiovascular diseases; heart failure; 10019280

• Registration Number: NL-OMON40889
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

healthy male subjects
45-65 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics:<br /><br>plasma drug concentrations, pharmacokinetic parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and tolerability:<br /><br>AEs, vital signs, ECG parameters, laboratory values**, physical examination.</p><br>