For PK parameters, linear mixed-effect models were applied in log-transformed PK parameters (Cmax, AUClast, and AUC0–24h) with treatment, period, and treatment sequence as fixed effects and participants as random effect. Geometric mean ratios (GMRs) between tests and references of Cmax and AUClast and the corresponding 90 % confidence intervals (CIs) were constructed following back-transformation. Descriptive statistics were used to describe PK parameters. Non-compartmental analysis with WinNonlin Professional software version 5.2.1 (Pharsight Corp, Mountain View, CA, USA) was used to calculate PK parameters for ibrutinib and metabolite PCI-45227. Concentrations below the lower level of quantifiable concentration were treated as zero in the summary statistics.
In studies 1 and 3, descriptive statistics were used for age, BMI, weight, and height in participants who received ≥1 dose of study drug. All participants who received ≥1 dose of study drug were included in the safety analyses. All AEs were recorded and followed throughout the study and follow-up.
In study 1, a sample size of 44 participants was planned based on statistical estimation to enable the study to provide an estimate on the magnitude of food effect with precision close to the limit of 80–125 %.
In studies 1 and 3, descriptive statistics were used for age, BMI, weight, and height in participants who received ≥1 dose of study drug. All participants who received ≥1 dose of study drug were included in the safety analyses. All AEs were recorded and followed throughout the study and follow-up.
In study 1, a sample size of 44 participants was planned based on statistical estimation to enable the study to provide an estimate on the magnitude of food effect with precision close to the limit of 80–125 %.