A Phase 1 interventional study of BI 1021958 and BI 1021958 in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-31.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Single rising dose (SRD) part
Drug: BI 1021958
Food effect part (FE)
Drug: BI 1021958
Matching placebo as drinking solution and tablets
Drug: Placebo to BI 1021958
tablet
drinking solution / tablet
SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast
Number of participants with clinically relevant findings in physical examination
Time frame: up to 14 days postdose
Number of participants with clinically relevant findings in vital signs
Time frame: up to 14 days postdose
Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to 14 days postdose
Number of participants with significant changes from baseline laboratory measurements
Time frame: up to 14 days postdose
Number of participants with adverse events
Time frame: up to 14 days postdose
Assessment of tolerability by investigator
Time frame: up to 14 days postdose
Cmax (maximum measured concentration of BI 1021958 in plasma)
Time frame: up to 72h postdose
area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: up to 72h postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
Time frame: up to 72h postdose
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim