Health TrialsbyHealthPanel

Study of Food Effects of VV913 Capsules in Chinese Healthy Volunteers

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorVigonvita Life Sciences

About this trial

This study is a single-center, randomized, open label, 3×3 crossover design to assess the high-fat meal and the standard meal effects on PK of a single oral dose of VV913 in healthy adult volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 45 years old, males ;

Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m²;

Vital signs examination, physical examination, laboratory examination ,Chest X-ray are normal or considered abnormal without clinical significance by the investigator;

Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;

Disqualifiers

Participants with hypersensitivity to preparation or any of the excipients;

Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;

Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials; Participants with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);

Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;

Trial design

Design model

Crossover

Treatments tested in this trial

  • VV913

    Drug

    A group：5 mg VV913, following an overnight fast of at least 10 hours for Period 1 ; 5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 2 ; 5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 3;

  • VV913

    Drug

    B group：5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 1 ; 5 mg VV913, following an overnight fast of at least 10 hours for Period 2 ; 5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 3;

  • VV913

    Drug

    C group：5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 1;5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 2 ; 5 mg VV913, following an overnight fast of at least 10 hours for Period 3 ;

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: A groupExperimental treatment 1 intervention
Group B: B groupExperimental treatment 1 intervention
Group C: C groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events

Incidence of Adverse Events

Time frame
From dosing to follow-up call (4 days after last dose of VV913)
2

Cmax

maximum observed plasma concentration of VV913

Time frame
72 hours after dosing
3

AUC0-∞

area under the plasma concentration time curve from time zero to infinity of VV913

Time frame
72 hours after dosing
4

AUC0-t

area under the plasma concentration time curve from time zero to the last of VV913

Time frame
72 hours after dosing

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vigonvita Life Sciences

Lead sponsor

Source ClinicalTrials.gov
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