Food Effect on Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers

NCT05221138 | Completed Phase 1

• 1 other identifier: VV116-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, randomized, open-label, three-period crossover design, the objective is to evaluate the pharmacokinetics and safety of VV116 tablets, which are orally administered to Chinese healthy volunteers after fasting, standard diet or high-fat diet.

Conditions

Healthy Subjects

Keywords

VV116; three-period crossover; food effect

Outcome Measures

Primary Outcomes (4)

• Evaluate high-fat diet and standard diet's effect on Cmax of VV116 tablets

  maximum observed plasma concentration

  From time zero up to 48 hours post-dose following oral administration of VV116

• Evaluate high-fat diet and standard diet's effect on AUC0-t of VV116 tablets

  area under the plasma concentration time curve from time zero to the last measurable concentration

  From time zero up to 48 hours post-dose following oral administration of VV116

• Evaluate high-fat diet and standard diet's effect on AUC0-∞ of VV116 tablets

  area under the plasma concentration-time curve from time zero to infinity

  From time zero up to 48 hours post-dose following oral administration of VV116

• Evaluate high-fat diet and standard diet's effect on Tmax of VV116 tablets

  time at which Cmax occurs

  From time zero up to 48 hours post-dose following oral administration of VV116

Secondary Outcomes (6)

• The incidence and severity of treatment emergent adverse event (TEAE) of clinical symptoms

  7 days after last treatment

• The incidence and severity of treatment emergent adverse event (TEAE) of vital signs

  7 days after last treatment

• The incidence and severity of treatment emergent adverse event (TEAE)of physical examinations

  7 days after last treatment

• The incidence and severity of treatment emergent adverse event (TEAE) of laboratory tests

  7 days after last treatment

• The incidence and severity of treatment emergent adverse event (TEAE) of physical examinations

  7 days after last treatment

Study Arms (3)

VV116 after High-fat meal intake

EXPERIMENTAL

a single oral after High-fat meal intake

Drug: VV116

VV116 after Fasting+Standard diet

EXPERIMENTAL

a single oral after Fasting

Drug: VV116

VV116 after Standard meal intake

EXPERIMENTAL

a single oral after Standard meal intake

Drug: VV116

Interventions

VV116 DRUG

VV116 oral tablets, 400mg

VV116 after Fasting+Standard diet; VV116 after High-fat meal intake; VV116 after Standard meal intake

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects between the ages of 18 and 45 years;
• Body weight no less than 50 kg for male, no less than 45 kg for female; Body Mass Index of 19 to 26kg/m2;
• Physical examination, vital signs examination, laboratory examination, ECG, B-ultrasound and fundus examination results were normal or abnormal without clinical significant;
• Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;
• 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;

You may not qualify if:

• Subjects with hypersensitivity to VV116 or any of the excipients;
• Subjects with allergic diseases or allergic constitution;
• Subjects with central nervous system,cardiovascular system,gastrointestinal, respiratory system,urinary,Hematologic System,metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
• Participated in a clinical study involving another investigational drug within 3 month before the screening visit;
• Taken any prescription drugs, non-prescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening;
• Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content) ;
• Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;
• Those who cannot quit smoking or drinking during the trial;
• Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
• Abnormal and clinically significant chest radiographs (anteroposterior);
• B ultrasound examination showed moderate to severe fatty liver;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper normal limit (ULN) at screening time or baseline;
• Glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2 at screening time or baseline;
• Abnormal ecg at screening or baseline, single QTcF (corrected for heart rate) \> 450 ms in men, \> 470 ms in women, and/or other clinically significant abnormalities;
• Pregnant or lactating women or male subjects whose spouse has a child care plan within 3 months;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Interventions

GS-621763

Study Officials

• Gangyi Liu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 2, 2022
• Study Start: December 30, 2021
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)