A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet (NCT03783000) | Clinical Trial Compass
CompletedPhase 1
A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet
Netherlands6 participantsStarted 2019-01-15
Plain-language summary
The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to \[C-14\]-BI 425809 administered as intravenous microtracer (Reference, R).
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion Criteria:
* Healthy male subjects according to the assessment of the investigator, 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 65 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
* Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication. Adequate methods are:
* Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
* Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
* Condoms plus surgically sterilised partner (including hysterectomy) or
* Condoms plus intrauterine device or
* Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner to the study drug via seminal fluid.
* Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyl…
What they're measuring
1
Area Under the Concentration-time Curve of the Analyte ([14C]-BI 425809 After iv Administration as Well as for BI 425809 After Oral Administration) Over the Time Interval From 0 to Infinity (AUC0-∞, Norm)
Timeframe: Pharmacokinetic samples were collected within 2 h before and up to 168 h after single oral administration of unlabelled BI 425809. Further details are in description.