1346.3.32001 Boehringer Ingelheim Investigational Site
Antwerp, Belgium
NCT Number: NCT02362516
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.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Antwerp, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tablet
Other names: Iclepertin
Time frame: 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.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).
Time frame: 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.
Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).
Time frame: 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).
Maximum measured concentration of BI 425809 in plasma is reported.
Time Frame:
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, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.
Time frame: 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.
Maximum measured concentration of BI 425809 in CSF is reported.
Time frame: 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.
Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.
Time frame: 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.
Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.
Time frame: From the first drug administration until 11 days after the last drug administration, up to 30days.
Percentage of participants with drug-related adverse events (AEs).
Boehringer Ingelheim
Industry
Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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