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Completed

NCT Number: NCT02001389

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven, Connecticut, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVP-6308

Drug

Arms 1, 2, 3, 4

Primary outcomes

  1. Target occupancy of [18F]MNI-659.

    Time frame: Baseline and Day 3

    Change in binding potential.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: Day 3

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

Sponsors and collaborators

Lead sponsor

FORUM Pharmaceuticals Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Dec 4, 2013
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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