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Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001 AM5)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00954538
First received: August 6, 2009
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

This study will estimate the radiochemical and radiation safety of [18F]MK3328, a novel positron emission tomography (PET) tracer.


Condition Intervention Phase
Alzheimer's Disease
 Drug: [18F]MK-3328
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Three Part Study to Evaluate the Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328, a Radiotracer for Use in Positron Emission Tomography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Safety and tolerability of [18F] MK3328 based on assessment of clinical and laboratory evaluations and adverse experiences [ Time Frame: Through 24 hours after the last dose of [18F]MK3328 ] [ Designated as safety issue: Yes ]
  • Effective dose of [18F] MK3328 [ Time Frame: 24 hours post dose ] [ Designated as safety issue: Yes ]
  • Radiation absorbed doses to individual organs [ Time Frame: 24 hours post dose ] [ Designated as safety issue: Yes ]
  • Mean difference in volume of distribution in brain regions of interest between Alzheimer's Disease (AD) participants and cognitively normal healthy participants [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part I, Healthy Participants, One dose Drug: [18F]MK-3328
Single intravenous (IV) dose of ~150 MBq [18F]MK-3328
Experimental: Part II, Healthy Participants and AD Participants, One dose Drug: [18F]MK-3328
Single intravenous (IV) dose of ~150 MBq [18F]MK-3328
Experimental: Part III, Healthy Participants and AD Participants, Two doses Drug: [18F]MK-3328
Two separate IV doses of ~150 MBq [18F]MK-3328

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Part I:

  • Participant is male or female of non-reproductive potential between 50 and 65 years old.
  • Participant is less than 6'5" tall
  • Participant is in good health
  • Participant has been a non-smoker for at least 10 years

Parts II and III:

  • Male or female of non-reproductive potential at least 55 years of age
  • Participant is cognitively normal, or has probable mild-to moderate AD
  • Participant is willing to have an arterial catheter placed in the radial artery (Part II only)

Exclusion Criteria:

Part I:

  • Participant has a history of stroke, seizures, or neurological disorder
  • Participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable

Parts II and III:

  • Participant has a history or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with altered cognition
  • Participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable
  • Participant is living in a nursing home or skilled nursing facility
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00954538     History of Changes
Other Study ID Numbers: 2009_630, MK3328-001
Study First Received: August 6, 2009
Last Updated: June 6, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013