Table 4.
(A) Descriptive and (B) Statistical Summaries of Plasma Abrocitinib Active Moiety Unbound Pharmacokinetic Parameters in Subjects With Normal Renal Function or Renal Impairment Following a Single 200‐mg Oral Dose of Abrocitinib
| (A) Pharmacokinetic Parameter Summary | |||
|---|---|---|---|
| Parameter, Unita | Normal Renal Function, N = 8 | Moderate Renal Impairment, N = 7 | Severe Renal Impairment, N = 8 |
| AUCinf,u, nM • h | 9955 (40) | 20920 (28) | 28940 (23) |
| AUClast,u, nM • h | 9710 (41) | 20680 (28) | 28670 (22) |
| Cmax,u, nM | 2099 (38) | 2810 (20) | 2718 (41)b |
| Adjusted (Least‐Squares) Geometric Means | ||||
|---|---|---|---|---|
| (B) Statistical Comparison | Test | Reference | Ratio (Test/Reference) of Adjusted Geometric Meansc | 90% CI for Ratioc |
| Moderate Renal Impairment (Test) Versus Normal Renal Function (Reference) | ||||
| AUCinf,u, nM • h | 20924.7 | 9954.8 | 210.20 | (154.60‐285.80) |
| AUClast,u, nM • h | 20682.9 | 9709.6 | 213.02 | (155.80‐291.24) |
| Cmax,u, nM | 2810.3 | 2099.3 | 133.87 | (102.45‐174.92) |
| Severe Renal Impairment (Test) Versus Normal Renal Function (Reference) | ||||
| AUCinf,u, nM • h | 28937.0 | 9954.8 | 290.68 | (217.39‐388.69) |
| AUClast,u, nM • h | 28675.0 | 9709.6 | 295.33 | (221.42‐393.90) |
| Cmax,u, nM | 2718.4 | 2099.3 | 129.49 | (92.86‐180.57) |
AUCinf,u, unbound area under the concentration‐time curve (AUC) from time 0 extrapolated to infinite time (AUCinf); AUClast,u, unbound AUC from time 0 to time of last quantifiable concentration; Cmax,u, unbound maximum plasma concentration; t1/2, terminal elimination half‐life; tmax, time to maximum plasma concentration.
N = total number of subjects in the treatment group in the indicated population.
aGeometric mean (geometric % coefficient of variation) for all.
bN = 7.
cThe ratios (and 90% CI) are expressed as percentages.