Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 (NCT02362516) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809
Belgium25 participantsStarted 2015-02-23
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)
Timeframe: 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
2
Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)
Timeframe: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
3
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
Timeframe: 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).
4
Maximum Measured Concentration of BI 425809 in CSF (Cmax)
Timeframe: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
5
Concentration of BI 425809 in Plasma at the Time Point 312h (C312)
Timeframe: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.
6
Concentration of BI 425809 in CSF at the Time Point 312h (C312)
Timeframe: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.