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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: EVP-6308

• Registration Number: NCT02001389
• Lead Sponsor: FORUM Pharmaceuticals Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-04
• Primary Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVP-6308; Arm 3	EVP-6308	high intermediate dose, Capsule, Once Daily, Day 1 through Day 3
EVP-6308; Arm 1	EVP-6308	low dose, Capsule, Twice Daily, Day 1 through Day 3
EVP-6308; Arm 2	EVP-6308	low intermediate dose, Capsule, Twice Daily, Day 1 through Day 3
EVP-6308; Arm 4	EVP-6308	high dose, Capsule, Once Daily, Day 1 through Day 3

Primary Outcome Measures

Name	Time	Method
Target occupancy of [18F]MNI-659.	Baseline and Day 3	Change in binding potential.

Secondary Outcome Measures

Name	Time	Method
Safety of EVP-6308 as assessed by adverse events, vital signs, clinical laboratory tests, C-SSRS, and electrocardiogram (ECG).	Baseline to Day 4 or Early Termination	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.
Pharmacokinetics of EVP-6308 and EVP-6308 N-oxide.	Day 3	Pharmacokinetic parameters to be determined include Cmax, Tmax, t1/2, and CL/F.