Phase 1
N=25
Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02362516 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) — 421.0; 829; 1840.0; 3300.0 nanomole*hours/Liter (nmol∙h/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 425809 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) |
421.0; 829; 1840.0; 3300.0 | — |
| PRIMARY Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14) |
29.9; 59.8; 124.0; 260.0 | — |
| PRIMARY Maximum Measured Concentration of BI 425809 in Plasma (Cmax) |
42.3; 85.6; 176; 328 | — |
| PRIMARY Maximum Measured Concentration of BI 425809 in CSF (Cmax) |
2.91; 5.59; 12.2; 25.0 | — |
| PRIMARY Concentration of BI 425809 in Plasma at the Time Point 312h (C312) |
66.7; 107; 266; 445 | — |
| PRIMARY Concentration of BI 425809 in CSF at the Time Point 312h (C312) |
5.62; 9.67; 21.7; 42.4 | — |
| SECONDARY Percentage of Participants With Drug-related Adverse Events (AEs) |
0; 0; 12.5; 0 | — |
Summary
To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.
Eligibility Criteria
Inclusion criteria
- Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (incl.)
- 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
Exclusion criteria
- Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator
- 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 Further exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02362516). 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.