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

NCT ID: NCT00954538

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-05-31

Brief Summary

This study will estimate the radiochemical and radiation safety and assess the efficacy of [18F]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses will test whether [18F]MK-3328 is sufficiently safe and well-tolerated, based on an assessment of clinical and laboratory evaluations and adverse experiences in healthy participants, including healthy elderly (HE) participants, and Alzheimer's disease (AD) participants, to permit continued investigation. The study efficacy hypothesis will test whether [18F]MK-3328 can discriminate between AD participants and cognitively normal elderly control participants based on tracer volume of distribution, or one of its surrogates, in brain posterior cingulate gyrus.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Part I, Healthy Participants

Healthy participants will receive a single intravenous (IV) dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part I of the study

Group Type: EXPERIMENTAL

[18F]MK-3328

Intervention Type: DRUG

IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328

Part II, HE and AD Participants

HE and AD participants will receive a single IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part II of the study

Group Type: EXPERIMENTAL

[18F]MK-3328

Intervention Type: DRUG

IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328

Part III, HE and AD Participants

HE and AD participants will receive two separate IV doses of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part III of the study

Group Type: EXPERIMENTAL

[18F]MK-3328

Intervention Type: DRUG

IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328

Interventions

[18F]MK-3328

IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328

Intervention Type: DRUG

Eligibility 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 (HE participants), or has probable mild-to moderate AD (AD participants)
• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2009_630

Identifier Type: OTHER

Identifier Source: secondary_id

3328-001

Identifier Type: -

Identifier Source: org_study_id