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dispersible of praziquantel

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last 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

Clinical trial landscape

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
HealthyUnlock trial analytics

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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Frequently asked questions about dispersible of praziquantel

What is dispersible praziquantel used for?

Dispersible praziquantel is an investigational small molecule being studied in healthy volunteers. It is a dispersible tablet formulation of praziquantel, an antiparasitic drug. The drug is currently in Phase 1 clinical development, and its use is being evaluated in healthy subjects to assess its bioavailability.

Who makes dispersible praziquantel?

Dispersible praziquantel is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.

What phase is dispersible praziquantel in?

Dispersible praziquantel is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial involving healthy volunteers.

What clinical trials is dispersible praziquantel in?

Dispersible praziquantel has one completed clinical trial, NCT02325713, titled 'Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers.' This Phase 1 study enrolled 32 healthy male participants in Germany and was a controlled, randomized trial.

Is dispersible praziquantel the same as praziquantel?

Dispersible praziquantel is a formulation of praziquantel, an antiparasitic medication. It is designed as a dispersible tablet for oral administration. The drug is being studied in healthy volunteers to evaluate its relative bioavailability compared to other forms.