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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: EVP-6308; Arm 1 | Experimental | low dose, Capsule, Twice Daily, Day 1 through Day 14 |
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| Experimental: EVP-6308; Arm 2 | Experimental | intermediate dose, Capsule, Once Daily, Day 1 through Day 14 |
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| Experimental: EVP-6308; Arm 3 | Experimental | high dose, Capsule, Once Daily, Day 1 through Day 14 |
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| Placebo Comparator; Arm 4 | Placebo Comparator | Placebo, Capsule, Once Daily, Day 1 through Day 14 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: EVP-6308 | Drug | Arms 1, 2, 3 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of EVP-6308 in subjects with schizophrenia and the potential for EVP-6308 to affect the pharmacokinetic properties of the antipsychotic regimen | PK parameters to be determined for EVP-6308 and EVP-6308 N-oxide metabolite include Cmax, Tmax,, AUC, and t1/2. PK parameters to be determined for the antipsychotic include Cmax, Tmax, AUC, and CL/F. | Day -1 through Day 16 |
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Inclusion Criteria:
• Diagnosed with schizophrenia, male or female subjects, 18 to 60 years of age
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach | California | United States |
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| Placebo | Drug | Arm 4 |
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| Potential pharmacodynamics effects of EVP-6308 | Quantitative EEG, Positive and Negative Syndrome Scale, Clinician Global Impression - Severity, Barnes Akathisia Rating Scale, Simpson-Angus Scale, Abnormal Involuntary Movement Scale, Cognitive Battery. | Baseline to Day 21 or Early Termination |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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