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Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Drug: EVP-6308
Placebo
Sponsored by
FORUM Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Phosphodiesterase 10 inhibitor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Diagnosed with schizophrenia, male or female subjects, 18 to 60 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental: EVP-6308; Arm 1

Experimental: EVP-6308; Arm 2

Experimental: EVP-6308; Arm 3

Placebo Comparator; Arm 4

Arm Description

low dose, Capsule, Twice Daily, Day 1 through Day 14

intermediate dose, Capsule, Once Daily, Day 1 through Day 14

high dose, Capsule, Once Daily, Day 1 through Day 14

Placebo, Capsule, Once Daily, Day 1 through Day 14

Outcomes

Primary Outcome Measures

Safety and tolerability of EVP-6308 in subjects with schizophrenia currently receiving stable treatment with up to 2 atypical antipsychotics
Vital signs measurements, Clinical laboratory tests, Physical examination, ECG findings, Columbia-Suicide Severity Rating Scale. Adverse events and concomitant medications will be collected from the time of signing the informed consent.

Secondary Outcome Measures

Pharmacokinetics of EVP-6308 in subjects with schizophrenia and the potential for EVP-6308 to affect the pharmacokinetic properties of the antipsychotic regimen
PK parameters to be determined for EVP-6308 and EVP-6308 N-oxide metabolite include Cmax, Tmax,, AUC, and t1/2. PK parameters to be determined for the antipsychotic include Cmax, Tmax, AUC, and CL/F.
Potential pharmacodynamics effects of EVP-6308
Quantitative EEG, Positive and Negative Syndrome Scale, Clinician Global Impression - Severity, Barnes Akathisia Rating Scale, Simpson-Angus Scale, Abnormal Involuntary Movement Scale, Cognitive Battery.

Full Information

First Posted
January 14, 2014
Last Updated
January 9, 2015
Sponsor
FORUM Pharmaceuticals Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02037074
Brief Title
Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics
Official Title
A Double-Blind, Escalating Dose Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Repeat Doses of EVP-6308 or Placebo in Subjects With Schizophrenia on a Stable Antipsychotic Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FORUM Pharmaceuticals Inc

4. Oversight

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308 administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Phosphodiesterase 10 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: EVP-6308; Arm 1
Arm Type
Experimental
Arm Description
low dose, Capsule, Twice Daily, Day 1 through Day 14
Arm Title
Experimental: EVP-6308; Arm 2
Arm Type
Experimental
Arm Description
intermediate dose, Capsule, Once Daily, Day 1 through Day 14
Arm Title
Experimental: EVP-6308; Arm 3
Arm Type
Experimental
Arm Description
high dose, Capsule, Once Daily, Day 1 through Day 14
Arm Title
Placebo Comparator; Arm 4
Arm Type
Placebo Comparator
Arm Description
Placebo, Capsule, Once Daily, Day 1 through Day 14
Intervention Type
Drug
Intervention Name(s)
Drug: EVP-6308
Intervention Description
Arms 1, 2, 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Arm 4
Primary Outcome Measure Information:
Title
Safety and tolerability of EVP-6308 in subjects with schizophrenia currently receiving stable treatment with up to 2 atypical antipsychotics
Description
Vital signs measurements, Clinical laboratory tests, Physical examination, ECG findings, Columbia-Suicide Severity Rating Scale. Adverse events and concomitant medications will be collected from the time of signing the informed consent.
Time Frame
Baseline to Day 21 or Early Termination
Secondary Outcome Measure Information:
Title
Pharmacokinetics of EVP-6308 in subjects with schizophrenia and the potential for EVP-6308 to affect the pharmacokinetic properties of the antipsychotic regimen
Description
PK parameters to be determined for EVP-6308 and EVP-6308 N-oxide metabolite include Cmax, Tmax,, AUC, and t1/2. PK parameters to be determined for the antipsychotic include Cmax, Tmax, AUC, and CL/F.
Time Frame
Day -1 through Day 16
Title
Potential pharmacodynamics effects of EVP-6308
Description
Quantitative EEG, Positive and Negative Syndrome Scale, Clinician Global Impression - Severity, Barnes Akathisia Rating Scale, Simpson-Angus Scale, Abnormal Involuntary Movement Scale, Cognitive Battery.
Time Frame
Baseline to Day 21 or Early Termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Diagnosed with schizophrenia, male or female subjects, 18 to 60 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
Facility Information:
City
Long Beach
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics

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