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.

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. - Single dose escalation study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45895

Enrollment

Registered

2018-11-20

Start date

2019-01-18

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructieve slaapapneu. Respiratory disorder sleep apnea

Interventions

Group 1: BAY 2253651 or placebo

5 µg Intravenous solution, once Group 2 to 5: BAY 2253651 or placebo, once by intravenous solution. Height of dose depends on the results of the previous groups.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
• Investigate the pharmacokinetics of BAY 2253651 after single ascending intravenous doses by means of the assessment of Cmax, AUC, Cmax/D and AUC/D. • Investigate the safety and tolerability of BAY 2253651 after single ascending intravenous doses by means of the incidence of treatment emergent adverse events (TEAEs).	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)