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MSC2499550A

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Jan 3, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

MSC2499550A · 1 trial · 1 indication

Phase 1 1
NCT02271984Relative Bioavailability Trial of L-Praziquantel in Healthy VolunteersHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Relative Bioavailability Trial of L-Praziquantel 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) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose

The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

Secondary Endpoints

Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ)
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose
Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ)
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of L-Praziquantel (L-PZQ) After Dose Adjustment
Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment A: MSC2499550AEXPERIMENTALMSC2499550A: 20 milligram per kilogram (mg/kg) under fed condition
Treatment B: CysticideEXPERIMENTALCysticide® 40 mg/kg under fed condition
Treatment C: MSC2499550AEXPERIMENTALC1:MSC2499550A :10 mg/kg under fed condition C2:MSC2499550A : 30 mg/kg under fed condition
Treatment D: MSC2499550AEXPERIMENTALMSC2499550A 20 mg/kg under fasting condition
Treatment E: MSC2499550AEXPERIMENTALMSC2499550A: 20 mg/kg directly disintegrated in mouth under fed condition

Interventions

NameTypeDescription
MSC2499550ADRUGSubjects 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.
CysticideDRUGSubjects 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.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 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 ...

Countries:Germany
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Frequently asked questions about MSC2499550A

What is MSC2499550A used for?

MSC2499550A is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The only completed trial evaluated its relative bioavailability in healthy male participants. It is not approved for any medical condition and remains under investigation.

Who makes MSC2499550A?

MSC2499550A is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this investigational small molecule. As of now, the drug is in Phase 1 development and has not been approved for any use.

What phase is MSC2499550A in?

MSC2499550A is in Phase 1 clinical development. One Phase 1 trial has been completed, with no active trials currently ongoing. The drug is investigational and has not received FDA approval. It is being studied in healthy volunteers to assess its bioavailability.

What clinical trials is MSC2499550A in?

MSC2499550A has one completed clinical trial, NCT02271984, titled "Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers." This Phase 1 study enrolled 36 healthy male participants in Germany. The trial was controlled but not double-blinded, and it has been completed.

Is MSC2499550A the same as L-Praziquantel?

MSC2499550A is not the same as L-Praziquantel. The completed clinical trial NCT02271984 studied the relative bioavailability of L-Praziquantel, but MSC2499550A is a distinct investigational small molecule. No alternative names for MSC2499550A have been established in the available data.