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

Phase 1CompletedNCT02001389

FORUM Pharmaceuticals Inc14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

EVP-6308DRUG

Arms 1, 2, 3, 4

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Target occupancy of [18F]MNI-659.

Change in binding potential.

Time frame: Baseline and Day 3

Secondary Outcomes

Safety of EVP-6308 as assessed by adverse events, vital signs, clinical laboratory tests, C-SSRS, and electrocardiogram (ECG).

The following will be evaluated: clinical laboratory evaluations (chemistry, hematology, coagulation and urinalysis), physical examination, directed neurological examination, vital signs, orthostatic blood pressure, 12-lead ECG, and assessment for suicidality. Adverse events and concomitant medications will be collected from the time of signing the informed consent.

Time frame: Baseline to Day 4 or Early Termination

Pharmacokinetics of EVP-6308 and EVP-6308 N-oxide.

Pharmacokinetic parameters to be determined include Cmax, Tmax, t1/2, and CL/F.

Time frame: Day 3

Data from ClinicalTrials.gov

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