Table 5.
Descriptive summary of urine lorlatinib pharmacokinetic parameters by renal function group
| Parameter (unit) | Normal function (n = 8) | Mild impairment (n = 8) | Moderate impairment (n = 8) | Severe impairment (n = 5) |
|---|---|---|---|---|
| Ae (mg) | 0.9441 ± 0.38542 | 1.218 ± 0.42974 | 0.8379 ± 0.54929 | 0.7836 ± 0.36385 |
| Ae (%) | 0.9441 ± 0.38542 | 1.218 ± 0.42974 | 0.8379 ± 0.54929 | 0.7836 ± 0.36385 |
| CLR (L/h) | 0.1095 (42) | 0.1382 (50) | 0.08199 (55) | 0.06872 (45) |
n number of participants contributing to the summary statistics
Data are geometric mean (geometric % coefficient of variation) for CLR except arithmetic mean ± standard deviation for Ae and Ae (%)
CLR for one participant in the normal renal function group was calculated based on Ae96 and AUClast since this participant’s last quantifiable plasma concentration was measured at 96 h
Ae96 cumulative amount of drug recovered unchanged in urine from time 0 to 96 h post dose, Ae cumulative amount of drug recovered unchanged in urine from time 0 to 120 h post dose, CLR renal clearance