Phase 1 N=96 Randomized Double-blind Treatment

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02337283 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I — 46.7; 50.0; 44.4; 66.7 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: BI 425809 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I	46.7; 50.0; 44.4; 66.7; 66.7; 66.7	—
PRIMARY Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Part II	7000; 8480	—
PRIMARY Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part II	241; 277	—
SECONDARY Percentage of Subjects With Drug Related Adverse Events (AEs) in Part II	0.0; 0.0	—
SECONDARY Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Part II	8770; 10600	—
SECONDARY Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) Part I	1410; 3720; 3460; 6020; 5620; 7170	—
SECONDARY Area Under the Concentration-time Curve of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) Part I	3870; 10600; 11000; 14200; 13900; 16500	—
SECONDARY Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part I	109; 278; 235; 397; 371; 451	—
SECONDARY Maximum Measured Concentration of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) Part I	221; 582; 618; 800; 802; 1020	—

Summary

The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.

Eligibility Criteria

Inclusion criteria

Healthy male or female subjects according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests
age of 18 to 50 years (incl.) for young healthy volunteers or age of 65 to 80 years (incl.) for elderly healthy volunteers
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Female subjects who meet any of the following criteria:
Surgically sterilised
Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg in young subjects, and systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 95 mmHg in elderly subjects, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as 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 trial medication
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
Further exclusion criteria may apply

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Data sourced from ClinicalTrials.gov (NCT02337283). 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.