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

NCT02037074 | Completed Phase 1

• 1 other identifier: EVP-6308-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Phosphodiesterase 10 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pharmacokinetics of EVP-6308 in subjects with schizophrenia and the potential for EVP-6308 to affect the pharmacokinetic properties of the antipsychotic regimen

  Day -1 through Day 16

• Potential pharmacodynamics effects of EVP-6308

  Baseline to Day 21 or Early Termination

Study Arms (4)

Experimental: EVP-6308; Arm 1

EXPERIMENTAL

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

Drug: Drug: EVP-6308

Experimental: EVP-6308; Arm 2

EXPERIMENTAL

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

Drug: Drug: EVP-6308

Experimental: EVP-6308; Arm 3

EXPERIMENTAL

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

Drug: Drug: EVP-6308

Placebo Comparator; Arm 4

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Drug: EVP-6308 DRUG

Arms 1, 2, 3

Experimental: EVP-6308; Arm 1; Experimental: EVP-6308; Arm 2; Experimental: EVP-6308; Arm 3

Placebo DRUG

Arm 4

Placebo Comparator; Arm 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• FORUM Pharmaceuticals Inc: lead

Study Sites (1)

Unknown Facility

Long Beach, California, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 15, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01

Locations

US (1)