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Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

NCT02068690 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-05-05

Study results available
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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

Conditions

  • Healthy

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-20
Primary Completion
2014-09-10
Completion
2014-09-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068690 on ClinicalTrials.gov