Status:
COMPLETED
A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Functional Magnetic Resonance Imaging
Eligibility:
MALE
21-45 years
Phase:
PHASE1
Brief Summary
This study will identify a dose of ferumoxytol that can reliably detect changes in blood flow/volume in response to non-drug stimuli. The study will determine whether signal detection for functional m...
Detailed Description
Study Design: Translational Medicine - Imaging Platform Development
Eligibility Criteria
Inclusion
- 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
- Participant has a contraindication to MRI including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, or any other MRI-incompatible metal implants that cannot be safely removed
- Participant has a condition that would limit his ability to complete MRI procedures, such as claustrophobia or chronic back pain
- Participant plans to undergo MRI studies in the 3 months following the post-study visit
- Participant has a history of hemochromatosis or other conditions of iron overload or disease of iron metabolism
- Participant has a known sensitivity to ferumoxytol or iron-containing products or has a history of severe allergies, anaphylactic reaction, or intolerance to drugs and/or foods
- Participant has a history of stroke, chronic seizures, or major neurological disorder
- Participant is unable to refrain from the use of any medication, including prescription and non-prescription drugs or herbal remedies from approximately 2 weeks prior to the first dose of ferumoxytol until the post-study visit
- Participant has a history of significant head injury/trauma with loss of consciousness lasting for 15 minutes and one or more of the following: a) recurring seizures resulting from head injury; b) persistent neurological or cognitive sequelae of the injury; c) cognitive rehabilitation following the injury
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01244282
Start Date
November 1 2010
End Date
April 1 2011
Last Update
June 10 2016
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