NCT02001389CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- FORUM Pharmaceuticals Inc
- Enrollment
- 14
- Primary Endpoint
- Target occupancy of [18F]MNI-659.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
EVP-6308; Arm 1
Experimental
low dose, Capsule, Twice Daily, Day 1 through Day 3
Intervention: EVP-6308 (Drug)
EVP-6308; Arm 2
Experimental
low intermediate dose, Capsule, Twice Daily, Day 1 through Day 3
Intervention: EVP-6308 (Drug)
EVP-6308; Arm 3
Experimental
high intermediate dose, Capsule, Once Daily, Day 1 through Day 3
Intervention: EVP-6308 (Drug)
EVP-6308; Arm 4
Experimental
high dose, Capsule, Once Daily, Day 1 through Day 3
Intervention: EVP-6308 (Drug)
Outcomes
Primary Outcomes
Target occupancy of [18F]MNI-659.
Time Frame: Baseline and Day 3
Change in binding potential.
Secondary Outcomes
- 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)
Investigators
Similar Trials
Recruiting
Phase 1
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsNCT06752681Day One Biopharmaceuticals, Inc.300
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901Pancreatic CancerNCT04805307Keymed Biosciences Co.Ltd176
Completed
Phase 1
A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid TumorsSolid TumorsNCT01603979AVEO Pharmaceuticals, Inc.24
Recruiting
Phase 1
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.High-grade GliomaWHO Grade Ⅳ GliomaNCT06482905Tcelltech Inc.52
Completed
Phase 1
Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisNCT06230822Wuhan Optics Valley Vcanbiopharma Co., Ltd.9