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

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02037074

Run by

FORUM Pharmaceuticals Inc

People needed

40

Starts

2014-06-01

Last updated by the study team

2015-01-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Study site — Long Beach, California, United States

Full record on ClinicalTrials.gov

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