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L-PZQ ODT

Phase 1

Healthy | Small molecule | Other |Merck KGaA|Trials Updated: Mar 6, 2017

L-PZQ ODT development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2014

L-PZQ ODT target and mechanism

ModalitySmall molecule

Also known as MSC 2499550A

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

L-PZQ ODT clinical trials

L-PZQ ODT · 1 trial · 1 indication

Phase 1 1
NCT02315352Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 YearsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years
Healthy
NCT0231535248
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Study Endpoints

Primary Endpoints

Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])
0 minute (Right After the Spit-out of the IMP)

Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.

Secondary Endpoints

Overall Palatability VAS Score at 2-5 Minutes
2-5 minutes (After the IMP has been spat out)
Number of Subjects With Mouth Feeling and Taste Description Evaluation
2-5 minutes (After the IMP has been spat out)
Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication
2-5 minutes
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Period 1 and 2EXPERIMENTALA-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue
Period 3, 4 and 5EXPERIMENTALC-D-E; C-E-D; D-E-C; D-C-E; E-C-D; E-D-C where C: L-PZQ ODT (MSC 2499550A) dispersed in water; D: Rac-PZQ ODT (MSC1028703A) dispersed in water; E: Cesol® 150 mg crushed in water

Interventions

NameTypeDescription
L-PZQ ODTDRUGL-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water
Rac-PZQ ODTDRUGRac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water
Cesol®DRUGCesol® tablet at a dose of 150 mg crushed in water
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Eligibility Criteria

Age Range6 Years to 11 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: 1. Children male or female aged 6-11 years (inclusive) 2. Parents or guardians gave written informed consent prior to any trial related procedure and child gave assent 3. Able to communicate well with the Investigator, understanding the protocol requirements and restrictions, an...

Countries:Tanzania
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