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

NCT ID: NCT02001389

Last Updated: 2014-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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EVP-6308; Arm 1

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

Group Type EXPERIMENTAL

EVP-6308

Intervention Type DRUG

Arms 1, 2, 3, 4

EVP-6308; Arm 2

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

Group Type EXPERIMENTAL

EVP-6308

Intervention Type DRUG

Arms 1, 2, 3, 4

EVP-6308; Arm 3

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

Group Type EXPERIMENTAL

EVP-6308

Intervention Type DRUG

Arms 1, 2, 3, 4

EVP-6308; Arm 4

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

Group Type EXPERIMENTAL

EVP-6308

Intervention Type DRUG

Arms 1, 2, 3, 4

Interventions

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EVP-6308

Arms 1, 2, 3, 4

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FORUM Pharmaceuticals Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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EVP-6308-002

Identifier Type: -

Identifier Source: org_study_id

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