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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02001389

Enrollment

Registered

2013-12-04

Start date

2013-10-31

Completion date

Unknown

Last updated

2014-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Enzyme occupancy, Positron emission tomography (PET), Phosphodiesterase 10 inhibitor

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.

Interventions

DRUGEVP-6308

Arms 1, 2, 3, 4

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026