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

FORUM Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: EVP-6308

Study type: Interventional

Funder types: Industry

Identifiers

NCT02001389

EVP-6308-002

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

EVP-6308; Arm 1

Experimental group

Description:

low dose, Capsule, Twice Daily, Day 1 through Day 3

Treatment:

Drug: EVP-6308

EVP-6308; Arm 2

Experimental group

Description:

low intermediate dose, Capsule, Twice Daily, Day 1 through Day 3

Treatment:

Drug: EVP-6308

EVP-6308; Arm 3

Experimental group

Description:

high intermediate dose, Capsule, Once Daily, Day 1 through Day 3

Treatment:

Drug: EVP-6308

EVP-6308; Arm 4

Experimental group

Description:

high dose, Capsule, Once Daily, Day 1 through Day 3

Treatment:

Drug: EVP-6308