Schizophrenia
Conditions
Brief summary
This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study
Detailed description
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.
Interventions
DRUGVV119(SAD)
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;
DRUGVV119 Placebo(SAD)
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;
DRUGVV119(FE)
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；
Sponsors
Vigonvita Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males:aged 18 to 45 years old, males ,Body weight no less than 50.0 kg ; females :Aged 18 to 60 years old ,Body weight no less than 45.0 kg ,Body Mass Index of 19.0 to 26.0kg/m2, 2. Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance, 3. Males subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed; females not of child-bearing potential, 4. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.
Exclusion criteria
Unless otherwise noted, the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 23 days after treatment in part Ⅰ; | Incidence of Treatment-Emergent Adverse Events |
| Cmax | 360 hours after dosing in part Ⅰ; | maximum observed plasma concentration of VV119 and the main metabolites |
| area under the plasma concentration time curve from time zero to the last(AUC0-t) | 360 hours after dosing in part Ⅰ; | area under the plasma concentration time curve from time zero to the last of VV119 and the main metabolites |
| AUC0-∞ | 360 hours after dosing in part Ⅰ; | area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites |
| Tmax | 360 hours after dosing in part Ⅰ; | time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites |
| t1/2 | 360 hours after dosing in part Ⅰ; | half life of elimination of VV119 and the main metabolites |
| Apparent Clearance Rate（CL/F） | 360 hours after dosing in part Ⅰ; | apparent clearance of VV119 and the main metabolites |
| Vd/F | 360 hours after dosing in part Ⅰ; | apparent volume of distribution during the terminal phase of VV119 and the main metabolites |
| Ke | 360 hours after dosing in part Ⅰ; | elimination rate constant of VV119 and the main metabolites |
| mean Resident Time from time zero to the last（MRT0-t） | 360 hours after dosing in part Ⅰ; | mean Resident Time from time zero to the last of VV119 of VV119 and the main metabolites |
| mean Resident Time from time zero to infinity（MRT0-∞) | 360 hours after dosing in part Ⅰ; | mean Resident Time from time zero to infinity of VV119 and the main metabolites |
| AUC_%Extra | 360 hours after dosing in part Ⅰ; | area under plasma Concentration (AUC) extrapolated of VV119 and the main metabolites |
| BP | 360 hours after dosing in part Ⅰ; | Blood Plasma Ratio of the main metabolites VV119-M2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolite Identification | 360 hours after dosing | Identification of the structure of the main metabolites of VV119 in plasma,Urine and feces |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORGang Wang
Beijing Anding Hospital of Capital Medical University
Outcome results
None listed