drugset / Trial / NCT00954538

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

NCT00954538 ↗

Phase 1 Completed 19 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2009-08
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject [18F]MK-3328 Diagnostic / imaging agent 150 mbq Intravenous

Indications