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 |
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.
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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