Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as L-PZQ
MSC2499550A · 1 trial · 1 indication
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
| Arm | Type | Description |
|---|---|---|
| Treatment A: MSC2499550A | EXPERIMENTAL | MSC2499550A: 20 milligram per kilogram (mg/kg) under fed condition |
| Treatment B: Cysticide | EXPERIMENTAL | Cysticide® 40 mg/kg under fed condition |
| Treatment C: MSC2499550A | EXPERIMENTAL | C1:MSC2499550A :10 mg/kg under fed condition C2:MSC2499550A : 30 mg/kg under fed condition |
| Treatment D: MSC2499550A | EXPERIMENTAL | MSC2499550A 20 mg/kg under fasting condition |
| Treatment E: MSC2499550A | EXPERIMENTAL | MSC2499550A: 20 mg/kg directly disintegrated in mouth under fed condition |
| Name | Type | Description |
|---|---|---|
| MSC2499550A | DRUG | Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each intervention period. |
| Cysticide | DRUG | Subjects will receive a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period. |
Inclusion Criteria: * Healthy males aged 18-55 years of age (inclusive at screening) * Male subjects with partners of childbearing potential must have had a vasectomy or use acceptable methods of birth control (that is, condoms) and not donate sperm during, and until 90 days after the last dose of ...