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Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
Sponsor: Boehringer Ingelheim
Summary
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Male Subjects (Partially Randomised, Single-blind, Placebo-controlled) and Investigation of Relative Bioavailability and Food Effect of BI 425809 (Open-label, Randomised, Three-way Crossover)
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2014-03-20
Completion Date
2014-09-10
Last Updated
2026-05-05
Healthy Volunteers
Yes
Conditions
Interventions
BI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
Placebo PfOS
Placebo as a powder for an oral solution (PfOS)
BI 425809 tablet
BI 425809 as a tablet
Locations (1)
1346.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany