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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037074
• Other study ID #: EVP-6308-003
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2014
• Last updated: January 9, 2015
• Start date: June 2014

Study information

• Verified date: January 2015
• Source: FORUM Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Drug: EVP-6308
Arms 1, 2, 3
• Placebo
Arm 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FORUM Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Day 21 or Early Termination	Yes
Secondary	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.	Day -1 through Day 16	No
Secondary	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.	Baseline to Day 21 or Early Termination	No