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TERMINATED
NCT04445090
PHASE1

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative bioavailability of BI 1569912

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2020-07-21

Completion Date

2021-09-10

Last Updated

2026-05-22

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BI 1569912

BI 1569912

DRUG

Placebo

Placebo

Locations (1)

Charité - Universitätsmedizin Berlin

Berlin, Germany