Phase 1 N=83 Randomized Treatment

Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02068690 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Number of Participants With Drug-related Adverse Events (AE) — 3; 1; 2; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: BI 425809 PfOS (Drug); Placebo PfOS (Drug); BI 425809 tablet (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Boehringer Ingelheim
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Drug-related Adverse Events (AE)	3; 1; 2; 1; 2; 1	—
SECONDARY SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)	10.0; 21.5; 42.3; 89.0; 171; 417	—
SECONDARY BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)	223; 329; 443	—
SECONDARY SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))	187; 404; 789; 1990; 4500; 8500	—
SECONDARY BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))	9260; 11900; 11400	—

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

Eligibility Criteria

Inclusion criteria

Healthy male subjects
Age 18 to 45 years (incl.)
Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Subject must be able to understand and comply with study requirements

Exclusion criteria

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure 140 mmHg, or diastolic blood pressure 90 mmHg, or pulse rate 90
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02068690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.