TABLE 4.
Statistical analysis of PK parameters for the ARA study
| PK parameter (unit) | Treatment | n* | Adjusted G mean | Comparison(s) | Treatment comparison | |
|---|---|---|---|---|---|---|
| G mean ratio | 90% CI | |||||
| AUCinf (ng*h/ml) | Asciminib | 23 | 9850 | Asciminib + rabeprazole / asciminib | 0.986 | 0.959–1.01 |
| Asciminib + rabeprazole | 23 | 9710 | ||||
| AUClast (ng*h/ml) | Asciminib | 23 | 9200 | Asciminib + rabeprazole / asciminib | 0.985 | 0.957–1.01 |
| Asciminib + rabeprazole | 23 | 9060 | ||||
| Cmax (ng/ml) | Asciminib | 23 | 943 | Asciminib + rabeprazole / asciminib | 0.908 | 0.849–0.972 |
| Asciminib + rabeprazole | 23 | 856 | ||||
| Tmax (h) | Asciminib | 23 | 2.00 | Asciminib + rabeprazole / asciminib | 1.00 | −1.00 to 3.00 |
| Asciminib + rabeprazole | 23 | 2.00 | ||||
Note: Model is a linear mixed effects model of the log‐transformed PK parameters. The model includes treatment as a fixed factor and subject as a random factor. The results are back transformed to get adjusted geometric mean, geometric mean ratio, and 90% CI.
n* = number of observations used for the analysis.
For Tmax, median is presented under “Adjusted geo‐mean,” median difference under “Geo‐mean ratio,” and minimum and maximum differences under 90% CI.
Abbreviations: ARA, acid‐reducing agent; AUC, area under the curve; AUCinf, AUC from zero to infinity; AUClast, AUC from zero to the last quantifiable concentration; CI, confidence interval; Cmax, maximum concentration of drug in plasma; G mean, geometric mean; PK, pharmacokinetic; Tmax, time to reach maximum concentration of drug in plasma.