Study of EVP-6308 to Assess the Dose- and Concentration-dependent Displacement of [18F]MNI-659 by EVP-6308



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:11/8/2014
Start Date:October 2013
Contact:Nathan Buerstatte
Email:nbuerstatte@forumpharma.com
Phone:617-374-5784

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A Phase 1, Open-Label, Multiple Ascending Dose, [18F]MNI-659 PET-Imaging Study to Evaluate PDE10A Occupancy After Dosing With EVP-6308 in Healthy Subjects

This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose-
and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting
phosphodiesterase 10 (PDE10)] by EVP-6308.


Inclusion Criteria:

• Healthy male or female volunteers, 18 to 50 years of age

Exclusion Criteria:

- Clinically significant abnormalities on physical examination, medical history, ECG ,
vital signs, laboratory values, or unstable medical or psychiatric illness

- Any disorder that may interfere with drug absorption.

- Clinically significant allergy or sensitivity to medications Positive test for human
immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C
antibody.

- Pregnant or breast feeding.

- History of exposure to any radiation >15 mSv/year (e.g., occupational or radiation
therapy) over the past year.
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