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Allyl Isothiocyanate

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 5, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06809569A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Healthy Participants (MK-0000-420)PHASE1 COMPLETED 12Sep 25, 2023Dec 15, 2023Feb 5, 20251 Belgium
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Study Endpoints
Primary Endpoints
Mean Dermal Blood Flow (DBF) in the Region of Interest (ROI)
Up to approximately 60 minutes

DBF is defined as the local changes in the skin blood flow after application of study intervention. DBF will be measured via a Laser Speckle Contrast Imager. The mean DBF in the ROI will be reported.

Area Under the Curve from Time 0 to 20 Minutes (AUC0-20) of Mean DBF in the ROI
Up to approximately 20 minutes

AUC0-20 is defined as the area under the curve from time 0-20 minutes. DBF is defined as the local changes in the skin blood flow after application of study intervention. DBF will be measured via a Laser Speckle Contrast Imager. AUC0-20 of mean DBF in ROI will be reported.

Area Under the Curve from Time 0 to 60 Minutes (AUC0-60) of Mean DBF in the ROI
Up to approximately 60 minutes

AUC0-60 is defined as the area under the curve from time 0-60 minutes. DBF is defined as the local changes in the skin blood flow after application of study intervention. DBF will be measured via a Laser Speckle Contrast Imager. AUC0-60 of mean DBF in ROI will be reported.

Secondary Endpoints
Change from Baseline in the Mean Intensity of DBF (Flare-1 Mean)
Baseline, Up to 60 minutes
Change from Baseline in the Area of DBF (Flare-1 Area)
Baseline, Up to 60 minutes
Change from Baseline in the Mean Intensity of DBF (Flare-2 Mean)
Baseline, Up to 60 minutes
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Laser Speckle Contrast ImagingEXPERIMENTALParticipants receive topical Allyl Isothiocyanate (AITC) application and intradermal capsaicin application sequentially along with a placebo comparator (vehicle for AITC and vehicle for capsaicin) once every 2 weeks per protocol to perform laser speckle contrast imaging.
Interventions
NameTypeDescription
Allyl Isothiocyanate (AITC)DRUGTopical administration
CapsaicinDRUGIntradermal administration
Vehicle for AITCOTHERTopical administration
Vehicle for CapsaicinOTHERIntradermal administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms performed before randomization * Has a skin surface without significant skin allergies, pigmentary disorders or active dermatological conditions that may interfere...

Countries:Belgium
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