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COMPLETED
NCT02068690
PHASE1

Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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

DRUG

BI 425809 PfOS

BI 425809 as a powder for an oral solution (PfOS)

DRUG

Placebo PfOS

Placebo as a powder for an oral solution (PfOS)

DRUG

BI 425809 tablet

BI 425809 as a tablet

Locations (1)

1346.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany