Humanpharmakologisches Zentrum Biberach
Biberach, 88397, Germany
NCT Number: NCT03403439
The primary objective of this trial is to investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the 4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral administration in healthy male subjects.
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Notify Me18 year–55 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
single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours
Other names: Nerandomilast, JASCAYD®
200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h
Time frame: Up to 215 hours (Please check measure description for detailed timeframe)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to 119 hours (h) (AUC0-119). Standard error is actually geometric standard error. Geometric mean (gMean) is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 hours:minutes (h:m) prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Time frame: Up to 215 hours (Please check measure description for detailed timeframe)
Maximum measured concentration of the BI 1015550 in plasma (Cmax). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Time frame: Up to 215 hours (Please check measure description for detailed timeframe)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Boehringer Ingelheim
Industry
Relative Bioavailability of a Single Oral Dose of BI 1015550 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects
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