Table 3.
Summary of Dosing and Up-Titration Schedules for Cohorts 1 to 4 (Pediatric Participants with Autism Spectrum Disorder)
| Intervention/postintervention day | 10–17 years |
5–9 years |
||||
|---|---|---|---|---|---|---|
| Cohort 1 |
Cohort 2 |
Cohort 3 |
Cohort 4 |
|||
| 10–12 years, 0.75 mg/day |
13–17 years, 1.5 mg/day |
10–12 years, 1.5 mg/day |
13–17 years, 3.0 mg/day |
0.5 mg/day |
1.5 mg/day |
|
| N = 6 | N = 6 | N = 6 | N = 6 | |||
| Day 1, mg (mL) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) |
| Day 2, mg (mL) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) |
| Day 3, mg (mL) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) | 0.5 (1) |
| Day 4, mg (mL) | 0.75 (1.5) | 1.5 (3) | 1.5 (3) | 1.5 (3) | 0.5 (1) | 1.5 (3) |
| Day 5, mg (mL) | 0.75 (1.5) | 1.5 (3) | 1.5 (3) | 1.5 (3) | 0.5 (1) | 1.5 (3) |
| Day 6, mg (mL) | 0.75 (1.5) | 1.5 (3) | 1.5 (3) | 1.5 (3) | 0.5 (1) | 1.5 (3) |
| Days 7–42 | 0.75 (1.5) | 1.5 (3) | 1.5 (3) | 3.0 (6) | 0.5 (1) | 1.5 (3) |
| Days 43–84 | PK follow-up | PK follow-up | PK follow-up | PK follow-up | PK follow-up | PK follow-up |
PK, pharmacokinetics.