Conditions: Healthy
Keywords: Healthy Praziquantel L-PZQ PZQ MSC2499550A Bioavailability Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: yes

Brief summary:
This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ \[MSC2499550A\]) oral dispersible tablet (ODT) formulation (150 milligram \[mg\]) versus the current marketed racemate praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers under fed conditions.

Detailed description:

Arms:
arm 1: MSC2499550A: 20 milligram per kilogram (mg/kg) under fed condition arm 2: Cysticide® 40 mg/kg under fed condition arm 3: C1:MSC2499550A :10 mg/kg under fed condition C2:MSC2499550A : 30 mg/kg under fed condition arm 4: MSC2499550A 20 mg/kg under fasting condition arm 5: MSC2499550A: 20 mg/kg directly disintegrated in mouth under fed condition

Interventions: intervention 1: MSC2499550A intervention 2: Cysticide intervention 3: MSC2499550A intervention 4: MSC2499550A intervention 5: MSC2499550A intervention 6: MSC2499550A
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Subjects will receive a single oral dose of MSC2499550A formulation at 10 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 of the intervention period. intervention 4: Subjects will receive a single oral dose of MSC2499550A formulation at 30 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 of the intervention period. intervention 5: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted 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. intervention 6: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.

Protocol document: