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| Name | Class |
|---|---|
| Alpharmagen, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 1 | Experimental |
| |
| Placebo Comparator: 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APN1125 | Drug | APN1125 orally at ascending doses |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety and tolerability of APN1125 in healthy subjects via adverse events | 8 days | |
| Assessment of safety and tolerability of APN1125 in healthy subjects via vital signs (e.g., blood pressure, pulse rate, respiratory rate, oral temperature) | 8 days | |
| Assessment of safety and tolerability of APN1125 in healthy subjects via ECGs | 8 days | |
| Assessment of safety and tolerability of APN1125 in healthy subjects via physical exams | 8 days | |
| Assessment of safety and tolerability of APN1125 in healthy subjects via clinical laboratory tests (chemistry, hematology, coagulation and urinalysis) | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: maximum observed plasma concentration (Cmax) | 24 hours | |
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: time corresponding to occurrence of Cmax (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Han, MD | California Clinical Trials Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Early Phase | Glendale | California | 91206 | 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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| Drug |
Matching Placebo |
|
| 24 hours |
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero to the last quantifiable concentration (AUClast) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: Area under the Curve from time zero extrapolated to infinity (AUCinf) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: terminal elimination rate constant (lz) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent elimination half-life (t1/2) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in plasma following single oral doses: apparent plasma clearance (CL/F) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: apparent volume of distribution (Vz/F) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion (Ae) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: fraction of APN1125 dose excreted (Fe) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: urinary excretion expressed as percentage of dose administered (Ae%) | 24 hours |
| Assessment of pharmacokinetics of APN1125 in urine following single oral doses: renal clearance calculated as APN1125 (CLR) | 24 hours |