Table 2.
Age | Cohort | Formulation | Final Recommen ded Dose | N* | Mean (%CV) Weight (kg) | Mean (%CV) Dose (mg/kg) | Observed Geometric Mean (%CV) AUC0-12hr (μM-hr) | Simulated Geometric Mean (%CV) AUC0-12hr (μM-hr) | Observed Geometric Mean (%CV) C12h (nM) | Simulated Geometric Mean (%CV) C12hr (nM) |
---|---|---|---|---|---|---|---|---|---|---|
6 months to <2 years | IV | Granules for suspension | 6 mg/kg twice daily | 8 | 8.5 (34) | 5.9 (7) | 19.8 (34) | 18.5 (34) | 108.2 (52) | 149.1 (88) |
| ||||||||||
4 weeks to <6 months | V | Granules for suspension | 6 mg/kg twice daily | 11 | 5.5(22) | 5.7 (12) | 22.3 (40) | 21.6 (47) | 116.6 (68) | 140.0 (117) |
Number of patients with intensive PK results at the final recommended dose