Single dose escalation study in a single center, randomized, single blind, placebo controlled, group comparison design to investigate pharmacokinetics, safety and tolerability of BAY 2253651 after intravenous administration in healthy male subjects.

• Conditions: obstructieve slaapapneu.; Respiratory disorder; sleep apnea

• Registration Number: NL-OMON45895
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

healthy white male volunteers
18 - 45 years of age
BMI 18.0 - 29.9 kilograms/meter2
non smokers

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 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 to the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Investigate the pharmacokinetics of BAY 2253651 after single ascending<br /><br>intravenous doses by means of the assessment of Cmax, AUC, Cmax/D and AUC/D.<br /><br>• Investigate the safety and tolerability of BAY 2253651 after single ascending<br /><br>intravenous doses by means of the incidence of treatment emergent adverse<br /><br>events (TEAEs).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>