NCT02271984

Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers

A Phase I, Open-Label, Randomized, Single Dose, Five Period, Crossover, Single Center Trial To Assess The Relative Bioavailability Of The 150 mg ODT Formulation Of L PZQ (MSC2499550A) Versus The Current 500 mg PZQ Commercial Racemate Tablet Formulation In Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MSC2499550A	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.
DRUG	Cysticide	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.
DRUG	MSC2499550A	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.
DRUG	MSC2499550A	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.
DRUG	MSC2499550A	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.
DRUG	MSC2499550A	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.

Timeline

• Start date: 2014-10-31
• Primary completion: 2014-12-31
• Completion: 2014-12-31
• First posted: 2014-10-22
• Last updated: 2018-01-03
• Results posted: 2018-01-03

Locations

1 site across 1 country: Germany