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fMRI with sensory stimulation

Phase 1

Functional Magnetic Resonance Imaging | Unknown | Other |Merck & Company, Inc.|Last Updated: Jun 10, 2016

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01244282A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)PHASE1 COMPLETED 10 — — Nov 1, 2010Apr 1, 2011Jun 10, 2016 - —
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Study Endpoints
Primary Endpoints
Magnitude of the MRI percent signal change in response to sensory stimulation without administration of ferumoxytol (BOLD fMRI)
45 minutes after initiation of imaging procedures
Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the first dose of ferumoxytol (250 mg)
55 minutes after initiation of imaging procedures
Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the second dose of ferumoxytol (100 mg, total cumulative dose of 350 mg)
70 minutes after initiation of imaging procedures
Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the third dose of ferumoxytol (180 mg, total cumulative dose of 510 mg)
85 minutes after initiation of imaging procedures
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
All ParticipantsEXPERIMENTALfMRI studies with sensory stimulation in the presence of 0 mg, 250 mg, 350 mg, and 510 mg cumulative doses of ferumoxytol
Interventions
NameTypeDescription
fMRI with sensory stimulationPROCEDUREBOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)
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Eligibility Criteria
Age Range21 Years — 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Participant weighs approximately 55-75 kg and has a Body Mass Index (BMI) of 18-25 kg/m\^2 * Participant is in good health * Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months Exclusion Criteria: * Participant has a ...

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