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

FORUM Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Drug: EVP-6308

Study type: Interventional

Funder types: Industry

Identifiers

NCT02037074

EVP-6308-003

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

Experimental: EVP-6308; Arm 1

Experimental group

Description:

low dose, Capsule, Twice Daily, Day 1 through Day 14

Treatment:

Drug: Drug: EVP-6308

Experimental: EVP-6308; Arm 2

Experimental group

Description:

intermediate dose, Capsule, Once Daily, Day 1 through Day 14

Treatment:

Drug: Drug: EVP-6308

Experimental: EVP-6308; Arm 3

Experimental group

Description:

high dose, Capsule, Once Daily, Day 1 through Day 14

Treatment:

Drug: Drug: EVP-6308

Placebo Comparator; Arm 4

Placebo Comparator group

Description:

Placebo, Capsule, Once Daily, Day 1 through Day 14

Treatment:

Drug: Placebo