CompletedPhase 1

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)

Germany96 participantsStarted 2015-01

Plain-language summary

The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Surgically sterilised
✓. Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

What they're measuring

frequency [N(%)] of subjects with drug related adverse events (AEs)

Timeframe: up to 25 days after first drug administration

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) only part II

Timeframe: up to 96 hours

Cmax (maximum measured concentration of the analyte in plasma) only part II

Timeframe: up to 96 hours

Trial details

NCT IDNCT02337283

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11

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