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dispersible of praziquantel

Phase 1

Healthy | Small molecule | Other |Merck KGaA|Trials Updated: Feb 23, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

dispersible of praziquantel clinical trials

dispersible of praziquantel · 1 trial · 1 indication

Phase 1 1
NCT02325713Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy VolunteersHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
Healthy
NCT0232571332
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Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ)
Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment

AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ.

Secondary Endpoints

Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence A-B-C1-D1EXPERIMENTAL -
Sequence A-B-C1-D2EXPERIMENTAL -
Sequence A-B-C2-D1EXPERIMENTAL -
Sequence A-B-C2-D2EXPERIMENTAL -
Sequence A-B-D1-C1EXPERIMENTAL -
Sequence A-B-D2-C1EXPERIMENTAL -
Sequence A-B-D1-C2EXPERIMENTAL -
Sequence A-B-D2-C2EXPERIMENTAL -
Sequence B-A-C1-D1EXPERIMENTAL -
Sequence B-A-C1-D2EXPERIMENTAL -
Sequence B-A-C2-D1EXPERIMENTAL -
Sequence B-A-C2-D2EXPERIMENTAL -
Sequence B-A-D1-C1EXPERIMENTAL -
Sequence B-A-D2-C1EXPERIMENTAL -
Sequence B-A-D1-C2EXPERIMENTAL -
Sequence B-A-D2-C2EXPERIMENTAL -

Interventions

NameTypeDescription
Oral dispersible tablet of praziquantel (ODT-PZQ)DRUGTreatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
CysticideDRUGTreatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQDRUGTreatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males 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 the t...

Countries:Germany
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