Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01476696 | A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease | PHASE2 | COMPLETED | 33 | — | — | Nov 1, 2011 | Nov 1, 2012 | Feb 13, 2014 | 9 | United States |
| NCT01430091 | A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet | PHASE1 | COMPLETED | 18 | — | — | Sep 1, 2011 | Oct 1, 2011 | Nov 6, 2012 | 1 | United States |
AUC of Pras-AM from time 0 up to the last sampling time of 4 hours postdose \[AUC(0-tlast)\] is reported by dose administered \[0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)\] during Part A (single-dose range finding phase) and is reported for doses administered on site (0.06, 0.08, and 0.12 mg/kg) during Part B (once-daily repeated dosing phase) of the study. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected.
Accumetrics VN assay: A point-of-care device that measures platelet aggregation. Percentage of platelet inhibition is reported by dose administered \[0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)\] during Part A (single-dose range finding phase) and also during the once-daily repeated dosing phase in Part B, at steady state, 14 ± 4 days after each new dose (0.06, 0.08, and 0.12 mg/kg) is administered. One participant received the same dose at multiple visits (Part A) and one participant received the same daily dose during both dosing periods in Part B.
| Arm | Type | Description |
|---|---|---|
| Part A: Prasugrel Single Dose | EXPERIMENTAL | Prasugrel 0.03 milligrams per kilogram (mg/kg) to 0.60 mg/kg dosage to be titrated up or down based on desired platelet inhibition, administered orally \[oral-disintegrating tablet (ODT)\], single dose given up to 3 occasions, at different strengths, with up to 18 days between doses. |
| Part B: Prasugrel Once-Daily Dose | EXPERIMENTAL | Daily prasugrel dose (mg/kg) that is expected to achieve mean platelet activation inhibition of 30% administered orally, once daily for 10-18 days and then followed by prasugrel dose (mg/kg) that is expected to achieve mean platelet activation inhibition of 50% administered orally, once daily for 10-18 days, for a total of 20-36 days. |
| Prasugrel clinical formulation | ACTIVE_COMPARATOR | A single 5-milligram (mg) prasugrel tablet administered orally by swallowing it whole on 1 occasion. |
| Prasugrel (ODT) - on tongue | EXPERIMENTAL | A single 5-mg prasugrel orally disintegrating tablet (ODT) administered orally by placing it on top of the tongue and keeping it there until it disintegrates. |
| Prasugrel (ODT) - apple juice | EXPERIMENTAL | A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue followed by drinking approximately 180 milliliters (ml) apple juice within 1 minute after the tablet finishes disintegration. |
| Prasugrel (ODT) - chewed | EXPERIMENTAL | A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue, but then chewed and swallowed rather than waiting for it to disintegrate. |
| Prasugrel (ODT) - under tongue | EXPERIMENTAL | A single 5-mg prasugrel ODT administered orally by placing it under (rather than on top of) the tongue and keeping it there until it disintegrates. |
| Name | Type | Description |
|---|---|---|
| Prasugrel | DRUG | Administered orally |
| Prasugrel (clinical formulation) | DRUG | Administered orally |
| Prasugrel (Orally Disintegrating Tablet [ODT]) | DRUG | Administered orally |
Inclusion Criteria: * Are male or female with SCD \[(homozygous sickle cell (HbSS) and hemoglobin S beta \^0 thalassemia (HbS β\^0 thalassemia)\] * Have a body weight ≥12 kilograms (kg) and are ≥2 to \<18 years of age at the time of screening * If participants are ≥2 and ≤16 years of age, have had ...