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 |
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.
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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