NCT02001389

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

October 10, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

November 27, 2013

Last Update Submit

October 9, 2014

Conditions

Healthy

Keywords

Enzyme occupancyPositron emission tomography (PET)Phosphodiesterase 10 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Target occupancy of [18F]MNI-659.

    Change in binding potential.

    Baseline and Day 3

Secondary Outcomes (2)

  • 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

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

    Day 3

Study Arms (4)

EVP-6308; Arm 1

EXPERIMENTAL

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

Drug: EVP-6308

EVP-6308; Arm 2

EXPERIMENTAL

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

Drug: EVP-6308

EVP-6308; Arm 3

EXPERIMENTAL

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

Drug: EVP-6308

EVP-6308; Arm 4

EXPERIMENTAL

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

Drug: EVP-6308

Interventions

EVP-6308DRUG

Arms 1, 2, 3, 4

EVP-6308; Arm 1EVP-6308; Arm 2EVP-6308; Arm 3EVP-6308; Arm 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female volunteers, 18 to 50 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

New Haven, Connecticut, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Last Updated

October 10, 2014

Record last verified: 2014-10

Locations

US(1)