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
NCT ID: NCT02037074
Last Updated: 2015-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental: EVP-6308; Arm 1
low dose, Capsule, Twice Daily, Day 1 through Day 14
Drug: EVP-6308
Arms 1, 2, 3
Experimental: EVP-6308; Arm 2
intermediate dose, Capsule, Once Daily, Day 1 through Day 14
Drug: EVP-6308
Arms 1, 2, 3
Experimental: EVP-6308; Arm 3
high dose, Capsule, Once Daily, Day 1 through Day 14
Drug: EVP-6308
Arms 1, 2, 3
Placebo Comparator; Arm 4
Placebo, Capsule, Once Daily, Day 1 through Day 14
Placebo
Arm 4
Interventions
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Drug: EVP-6308
Arms 1, 2, 3
Placebo
Arm 4
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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FORUM Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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Long Beach, California, United States
Countries
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Other Identifiers
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EVP-6308-003
Identifier Type: -
Identifier Source: org_study_id
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