Humanpharmakologisches Zentrum Biberach
Biberach, 88397, Germany
NCT Number: NCT03837964
To assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1291583, by investigating the relative bioavailability following single dose administration under fed and fasted conditions.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Biberach, 88397, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tablet
Other names: Verducatib
Time frame: Within 3 hours (h) before and 0.5, 1, 2, 4, 5, 6, 7, 8, 10, 12, 14, 24, 34, 48, 72, 96, 120, 168, 216, 264 hours after drug administration
Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable data point.
Time frame: Within 3 hours (h) before and 0.5, 1, 2, 4, 5, 6, 7, 8, 10, 12, 14, 24, 34, 48, 72, 96, 120, 168, 216, 264 hours after drug administration
Maximum measured concentration of BI 1291583 in plasma
Time frame: Within 3 hours (h) before and 0.5, 1, 2, 4, 5, 6, 7, 8, 10, 12, 14, 24, 34, 48, 72, 96, 120, 168, 216, 264 hours after drug administration
AUC0-inf represents the area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 extrapolated to infinity
Boehringer Ingelheim
Industry
Relative Bioavailability of BI 1291583 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)
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