Study of Food Effects of VV119 Capsules in Chinese Healthy Volunteers
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVigonvita Life Sciences
About this trial
This study is a single-center, randomized, open label, 2×2 crossover design to assess the standard meal effects on PK of a single oral dose of VV119 in healthy adult subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance,
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,
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.
Disqualifiers
With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial;
With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation;
With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.
With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution;
Trial design
Design model
Crossover
Treatments tested in this trial
VV119
DrugA：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 Standard meal for Period 2;
VV119
DrugB: 2mg VV119, administered 30 minutes after the start of a Standard meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2；
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: A groupExperimental treatment 1 intervention
Group B: B groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame
Dosing through follow-up call (7 days after last dose of investigational product)2
Cmax
maximum observed plasma concentration of the main metabolites VV119-M2
Time frame
480 hours after dosing3
AUC0-∞
area under the plasma concentration time curve from time zero to infinity of the main metabolites VV119-M2
Time frame
480 hours after dosing4
AUC0-t
area under the plasma concentration time curve from time zero to the last of the main metabolites VV119-M2
Time frame
480 hours after dosingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov