Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects (NCT02383888) | Clinical Trial Compass
CompletedPhase 1
Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects
South Korea49 participantsStarted 2015-05-11
Plain-language summary
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product.
Who can participate
Age range20 Years – 45 Years
SexMALE
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Inclusion criteria:
* Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age 20 to 45 years (incl.)
* BMI 18.5 to 25 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
* Chinese ethnicity, Japanese ethnicity according to the following criteria:
* Chinese: ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
* Japanese: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who were all born in Japan
Exclusion criteria:
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
* Repeated measurement of systolic blood pressure \<90 or \>140 mmHg, or diastolic blood pressure \<50 or \>90 mmHg, or PR \<50 or \>90
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged 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 centra…
What they're measuring
1
Number of Subjects With Drug-Related Adverse Events (AEs)
Timeframe: Up to 11 days after drug administration.