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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo

• Registration Number: NCT02037074
• Lead Sponsor: FORUM Pharmaceuticals Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Study Start: 2014-06
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-09
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator; Arm 4	Placebo	Placebo, Capsule, Once Daily, Day 1 through Day 14

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of EVP-6308 in subjects with schizophrenia currently receiving stable treatment with up to 2 atypical antipsychotics	Baseline to Day 21 or Early Termination	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

Name	Time	Method
Pharmacokinetics of EVP-6308 in subjects with schizophrenia and the potential for EVP-6308 to affect the pharmacokinetic properties of the antipsychotic regimen	Day -1 through Day 16	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	Baseline to Day 21 or Early Termination	Quantitative EEG, Positive and Negative Syndrome Scale, Clinician Global Impression - Severity, Barnes Akathisia Rating Scale, Simpson-Angus Scale, Abnormal Involuntary Movement Scale, Cognitive Battery.