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Study of Food Effects of VV261 Tablets in Healthy Trial Participants

4 novembre 2026 aggiornato da: Vigonvita Life Sciences

This is a single-center, randomized, open-label, three-cycle, self-cross-over study on human pharmacokinetic characteristics under fasting, standard meal, and high-fat meal conditions.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a single-center, randomized, open-label, three-cycle, self-crossed trial designed with a dosage of 600 mg and a washout period of 8 days. The study is expected to enroll 15 trial participants. The 15 participants will be randomly assigned to three groups:A, B, and C,with 5 participants in each group. In Group A, administration during the first cycle will be performed under fasting conditions; during the second cycle, under standard postprandial conditions; and during the third cycle, under high-fat postprandial conditions. In Group B, administration during the first cycle will be performed under high-fat postprandial conditions; during the second cycle, under fasting conditions; and during the third cycle, under standard postprandial conditions. In Group C, administration during the first cycle will be performed under standard postprandial conditions; during the second cycle, under high-fat postprandial conditions; and during the third cycle, under fasting conditions.

Tipo di studio

Interventistico

Iscrizione (Stimato)

15

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Anhui
      • Hefei, Anhui, Cina, 230031
        • The First Affiliated Hospital of Anhui Medical University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Aged 18 to 45 years old, males or females;
  2. Males weight no less than 50 kg, females weight no less than 45 kg, with body mass index of 19 to 26 kg/m^2;
  3. Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT and B-ultrasound of liver, gallbladder, pancreas, spleen, kidney and thyroid results are normal or considered abnormal without clinical significance by the investigator;
  4. Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
  5. Participants who are able to understand and follow the study protocol and instructions; participants who have voluntarily decided to participate in this study, and sign the informed consent form.

Exclusion Criteria:

  1. Participants with hypersensitivity to preparation or any of the excipients;
  2. Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
  3. 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 previous surgery that may significantly affect the body's metabolic process or safety evaluation of the study drug (such as liver, gallbladder, kidney, splenectomy, gastrointestinal resection or excessive blood loss that affects drug absorption, distribution, metabolism)
  4. Participants with a history of diseases affecting bone marrow hematopoietic function or reducing immunological function (including leukemia, myelodysplastic syndrome, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis, etc.) or treatment history (tumor chemotherapy or radiotherapy, use of immunosuppressants, etc.);
  5. Participants with a history of spleen diseases;
  6. If any of the following parameters were considered abnormal with clinical significance: white blood cell count, red blood cell count, platelet count, reticulocyte count, and absolute neutrophil count;
  7. If any of the following parameters were considered abnormal with clinical significance: total bilirubin, alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase;
  8. Participants who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (excluding menstruation);
  9. Participants who have participated in clinical trials and received drugs within 3 months before screening;
  10. Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening;
  11. Participants who have received vaccination within the first 2 weeks before screening, or planned to receive any vaccine within 1 week after the end of the study;
  12. Participants with a history of drug abuse within 1 year before screening or positive urine drug screening within 1 year before screening results (morphine, tetrahydrocannabinol, methamphetamine, dimethylene diphenazine , ketamine, and cocaine);
  13. Participants who drink more than 14 standard units or at least twice a day per week within one year before screening,(one standard unit equals 200 mL of beer with 5% alcohol or 25 mL of white wine with 40% alcohol content or 85 mL of red wine with 12% alcohol) or participants with breath alcohol test >0 mg/100 mL;
  14. Participants who smok more than 5 cigarettes a day within one year before screening;
  15. Participants who can't quit smoking or drinking during the trial period;
  16. Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV);
  17. Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
  18. Participants with lactose intolerance or cannot comply with a uniform diet (such as special dietary requirements, intolerance of standard meals, etc.), Participants who have consumed excessive amounts of strong tea, coffee or caffeinated beverages in the 3 months before screening;
  19. Participants with difficulty in swallowing tablets;
  20. Pregnant or lactating women; participants whose spouses or partners intend to become pregnant, plan sperm or oocyte donation within 3 months after the last dose, or decline to use acceptable effective contraception;
  21. The investigator believes that there are other unsuitable factors to participate this trial.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Un gruppo

A group:600 mg VV261, following an overnight fast of at least 10 hours for Period 1 ;600 mg VV261, administered 30 minutes after the start of a Standard meal for Period 2 ; 600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 3;

B group:600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 1 ; 600 mg VV261, following an overnight fast of at least 10 hours for Period 2 ; 600 mg VV261, administered 30 minutes after the start of a Standard meal for Period 3;

C group:administered 30 minutes after the start of a Standard meal for Period 1;600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 2 ; 600 mg VV261, following an overnight fast of at least 10 hours for Period 3 ;

Sperimentale: Gruppo B

A group:600 mg VV261, following an overnight fast of at least 10 hours for Period 1 ;600 mg VV261, administered 30 minutes after the start of a Standard meal for Period 2 ; 600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 3;

B group:600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 1 ; 600 mg VV261, following an overnight fast of at least 10 hours for Period 2 ; 600 mg VV261, administered 30 minutes after the start of a Standard meal for Period 3;

C group:administered 30 minutes after the start of a Standard meal for Period 1;600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 2 ; 600 mg VV261, following an overnight fast of at least 10 hours for Period 3 ;

Sperimentale: C group

A group:600 mg VV261, following an overnight fast of at least 10 hours for Period 1 ;600 mg VV261, administered 30 minutes after the start of a Standard meal for Period 2 ; 600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 3;

B group:600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 1 ; 600 mg VV261, following an overnight fast of at least 10 hours for Period 2 ; 600 mg VV261, administered 30 minutes after the start of a Standard meal for Period 3;

C group:administered 30 minutes after the start of a Standard meal for Period 1;600 mg VV261, administered 30 minutes after the start of the high-fat meal for Period 2 ; 600 mg VV261, following an overnight fast of at least 10 hours for Period 3 ;

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Treatment-Emergent Adverse Events
Lasso di tempo: Baseline to 7days after the last administration

Incidence of Treatment-Emergent Adverse Events

Baseline to 7days after the last administration
Cmax
Lasso di tempo: Baseline to 96 hours after the last administration

Maximum observed plasma concentration

Baseline to 96 hours after the last administration
Tmax
Lasso di tempo: Baseline to 96 hours after the last administration

Time at which Cmax occurs

Baseline to 96 hours after the last administration
AUC0-t
Lasso di tempo: Baseline to 96 hours after the last administration

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

Baseline to 96 hours after the last administration
AUC0-∞
Lasso di tempo: Baseline to 96 hours after the last administration

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

Baseline to 96 hours after the last administration
t1/2
Lasso di tempo: Baseline to 96 hours after the last administration

Half life of elimination

Baseline to 96 hours after the last administration
CL/F
Lasso di tempo: Baseline to 96 hours after the last administration

Apparent clearance

Baseline to 96 hours after the last administration
mean Resident Time
Lasso di tempo: Baseline to 96 hours after the last administration

Mean Resident Time from time zero to infinity/the last

Baseline to 96 hours after the last administration
Vd/F
Lasso di tempo: Baseline to 96 hours after the last administration

Apparent volume of distribution during the terminal phase

Baseline to 96 hours after the last administration

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Huan Zhou, The First Affiliated Hospital of Anhui Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

9 novembre 2026

Completamento primario (Stimato)

30 dicembre 2026

Completamento dello studio (Stimato)

30 gennaio 2027

Date di iscrizione allo studio

Primo inviato

4 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • VV261-03

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .