Table 3.
Pharmacokinetic results by palovarotene dose and Japanese/non-Japanese group
| Parameter, units | Palovarotene 5 mg | Palovarotene 10 mg | ||
|---|---|---|---|---|
| Japanese participants (N = 10) | Non-Japanese participants (N = 8) | Japanese participants (N = 10) | Non-Japanese participants (N = 8) | |
| AUC(0–∞), h·ng/mL | ||||
| Geometric meana | 214.7 | 240.6 | 428.8 | 451.2 |
| Coefficient of variation %b | 29.5 | 45.7 | 27.0 | 43.6 |
| 90% CIa | (176.9, 260.5) | (193.8, 298.7) | (353.4, 520.3) | (363.5, 560.2) |
| Ratio of geometric meana | 0.9 | 1.0 | ||
| 90% CI for ratioa | (0.7, 1.2) | (0.7, 1.3) | ||
| AUC(0–z), h·ng/mL | ||||
| Geometric meana | 213.9 | 240.1 | 427.8 | 448.3 |
| Coefficient of variation %b | 29.2 | 45.8 | 26.9 | 44.4 |
| 90% CIa | (176.2, 259.8) | (193.3, 298.4) | (352.3, 519.5) | (360.8, 557.0) |
| Ratio of geometric meana | 0.9 | 1.0 | ||
| 90% CI for ratioa | (0.7, 1.2) | (0.7, 1.3) | ||
| Cmax, ng/mL | ||||
| Geometric meana | 38.2 | 39.7 | 74.4 | 77.9 |
| Coefficient of variation %b | 42.7 | 37.9 | 29.0 | 30.6 |
| 90% CIa | (31.6, 46.2) | (32.1, 49.1) | (61.5, 90.1) | (63.0, 96.4) |
| Ratio of geometric meana | 1.0 | 1.0 | ||
| 90% CI for ratioa | (0.7, 1.3) | (0.7, 1.3) | ||
aGeometric means and CIs obtained from a mixed model with fixed effects for groups and doses and a random participant effect. bCoefficient of variation % = (sqrt((exp(variance of natural log-transformed data)) - 1)) × 100
AUC area under the plasma concentration–time curve, AUC(0–z) AUC from time zero to the last timepoint, AUC(0–∞) AUC from time zero to infinity, CI confidence interval, Cmax maximum plasma drug concentration, N number of participants