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The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMS643762 Low Dose | Experimental | Orally administering OMS643762 low dose daily for 14 days |
|
| OMS643762 High Dose | Experimental | Orally administering OMS643762 high dose daily for 14 days |
|
| Placebo | Placebo Comparator | Orally administering placebo daily for 14 days |
|
| OMS643762 Medium Dose | Experimental | Orally administering OMS643762 medium dose daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMS643762 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Incidence of adverse events | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Maximum plasma concentration of OMS643762 following multiple-dose administration | Pre-dose and up to 10 days post-dose |
| Pharmacokinetics | Area under the concentration-time curve of OMS643762 following multiple-dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Yu, MD | Omeros Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach | California | 90806 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug |
|
| Pre-dose and up to 10 days post-dose |
| Cognition | Time to complete the Trail Making Test | Pre-dose and on day 14 of dosing |
| Cognition | Number of correct responses on the Stroop Color and Word Test | Pre-dose and on day 14 of dosing |
| Cognition | Number of correct responses on the Hopkin's Verbal Learning Test-Revised | Pre-dose and on day 14 of dosing |