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This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study
Part Ⅰ were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) of single oral doses of VV119 in healthy adult subjects.
Part Ⅱ is a single-center, randomized, open label, 2×2 crossover design to assess the high-fat meal effects on PK of a single oral dose of VV119 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part Ⅰ - Single Ascending Dose (SAD) study: Experimental | Experimental | Subjects will receive VV119 orally for single dose. |
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| Part Ⅰ - Single Ascending Dose (SAD) study: Placebo | Experimental | Subjects will receive VV119 placebo orally for single dose. |
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| Part Ⅱ - Food Effect (FE) study: Experimental | Experimental | Subjects will receive VV119 orally for single dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV119(SAD) | Drug | VV119 0.2 mg Group: 2 subjects will receive VV119 0.2 mg, orally; VV119 0.5 mg Group: 6 subjects will receive VV119 0.5 mg, orally; VV119 1 mg Group: 6 subjects will receive VV119 1 mg, orally; VV119 2 mg Group: 6 subjects will receive VV119 2 mg, orally; VV119 3 mg Group:6 subjects will receive VV119 3 mg, orally; VV119 4.5 mg Group:6 subjects will receive VV119 4.5 mg, orally; VV119 6 mg Group:6 subjects will receive VV119 6 mg, orally; VV119 8 mg Group:6 subjects will receive VV119 8 mg, orally; VV119 10 mg Group:6 subjects will receive VV119 10 mg, orally; |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | 23 days after treatment in part Ⅰ; |
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events | 56 days after treatment in part Ⅱ; |
| Cmax | maximum observed plasma concentration of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| Cmax | maximum observed plasma concentration of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| area under the plasma concentration time curve from time zero to the last(AUC0-t) | area under the plasma concentration time curve from time zero to the last of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| area under the plasma concentration time curve from time zero to the last(AUC0-t) | area under the plasma concentration time curve from time zero to the last of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| AUC0-∞ | area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite Identification | Identification of the structure of the main metabolites of VV119 in plasma,Urine and feces | 360 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
Unless otherwise noted, the exclusion criteria were consistent for subjects in the SAD study and FE study. The following subjects will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaqing Duan | Contact | +8618061926005 | huaqing.duan@vigonvita.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Wang | Beijing Anding Hospital of Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital of Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100088 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| VV119 Placebo(SAD) | Drug | VV119 0.5 mg Group: 2 subjects will receive VV119 Placebo 0.5 mg, orally; VV119 1 mg Group: 2 subjects will receive VV119 Placebo 1 mg, orally; VV119 2 mg Group: 2 subjects will receive VV119 Placebo 2 mg, orally; VV119 3 mg Group:2 subjects will receive VV119 Placebo 3 mg, orally; VV119 4.5 mg Group:2 subjects will receive VV119 Placebo 4.5 mg, orally; VV119 6 mg Group:2 subjects will receive VV119 Placebo 6 mg, orally; VV119 8 mg Group:2 subjects will receive VV119 Placebo 8 mg, orally; VV119 10 mg Group:2 subjects will receive VV119 Placebo 10 mg, orally; |
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| VV119(FE) | Drug | A:2 mg VV119, following an overnight fast of at least 10 hours for Period 1; 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 2; B: 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2; |
|
| AUC0-∞ | area under the plasma concentration time curve from time zero to infinity of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| Tmax | time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| Tmax | time at which Cmax occurs of VV119 and the main metabolites of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| t1/2 | half life of elimination of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| t1/2 | half life of elimination of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| Apparent Clearance Rate(CL/F) | apparent clearance of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| Apparent Clearance Rate(CL/F) | apparent clearance of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| Vd/F | apparent volume of distribution during the terminal phase of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| Vd/F | apparent volume of distribution during the terminal phase of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| Ke | elimination rate constant of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| Ke | elimination rate constant of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| mean Resident Time from time zero to the last(MRT0-t) | mean Resident Time from time zero to the last of VV119 of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| mean Resident Time from time zero to the last(MRT0-t) | mean Resident Time from time zero to the last of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| mean Resident Time from time zero to infinity(MRT0-∞) | mean Resident Time from time zero to infinity of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| mean Resident Time from time zero to infinity(MRT0-∞) | mean Resident Time from time zero to infinity of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| AUC_%Extra | area under plasma Concentration (AUC) extrapolated of VV119 and the main metabolites | 360 hours after dosing in part Ⅰ; |
| AUC_%Extra | area under plasma Concentration (AUC) extrapolated of the main metabolites VV119-M2 | 480 hours after dosing in part Ⅱ; |
| BP | Blood Plasma Ratio of the main metabolites VV119-M2 | 360 hours after dosing in part Ⅰ; |
| BP | Blood Plasma Ratio of VV119 and the main metabolites | 480 hours after dosing in part Ⅱ; |