イトラコナゾールが血中のBI 1584862の量に影響を与えるかどうかを試験する健康な男性を対象とした研究

実験的：BI 1584862 (R), then BI 1584862 + itraconazole (T)

Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period.

薬：BI 1584862

One dose with 240 mL of water after an overnight fast of at least 10 h

薬：Itraconazole

200 mg daily after an overnight fast of at least 9 h for several consecutive days

Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

Maximum Measured Concentration of BI 1584862 in Plasma (Cmax)

Maximum measured concentration of BI 1584862 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.