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



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:2/7/2015
Start Date:June 2014
Contact:Nathan Buerstatte
Email:nbuerstatte@forumpharma.com
Phone:617-374-5784

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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

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.


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
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