- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07565792
Study of Food Effects of VV913 Capsules in Chinese Healthy Volunteers
11 juillet 2026 mis à jour par: Vigonvita Life Sciences
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
12
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Huaqing Duan
- Numéro de téléphone: 18061926005
- E-mail: huaqing.duan@vigonvita.cn
Lieux d'étude
-
-
Anhui
-
Hefei, Anhui, Chine, 230031
- Recrutement
- The First Affiliated Hospital of Anhui Medical University
-
Contact:
- Huan Zhou
- Numéro de téléphone: 13665527160
- E-mail: zhouhuanbest@vip.163.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Aged 18 to 45 years old, males ;
- Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m^2;
- 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;
- 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:
- 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;
- Participants with a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a history of blood product use within 3 months before screening;
- Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
- Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening;
- Participants who have received vaccination within 14 days before screening, or planned to receive any vaccine during the trial or within 1 week after the end of the study;
- 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);
- 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 spirits with 40% alcohol content or 85 mL of wine with 12% alcohol content);
- Participants who smoke more than 5 cigarettes a day within one year before screening;
- Participants who can't quit smoking or drinking during the trial period;
- Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV);
- Having special requirements for food, unable to observe a unified diet or having dysphagia;
- Participants who cannot avoid consuming drinks containing xanthine (such as coffee and tea) or foods (such as chocolate and animal liver), or fruits or juices (such as grapefruit, pomelo, mango, and dragon fruit) that may affect drug metabolism,from 48 hours before administration until the end of the study;
- Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
- Participants with difficulty in swallowing capsules;
- Participants whose female partners plan to conceive within 3 months;
- The investigator believes that there are other unsuitable factors to participate this trial.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Un groupe
|
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;
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;
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 ;
|
|
Expérimental: Groupe B
|
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;
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;
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 ;
|
|
Expérimental: C group
|
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;
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;
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 ;
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Adverse Events
Délai: From dosing to follow-up call (4 days after last dose of VV913)
|
Incidence of Adverse Events
|
From dosing to follow-up call (4 days after last dose of VV913)
|
|
Cmax
Délai: 72 hours after dosing
|
maximum observed plasma concentration of VV913
|
72 hours after dosing
|
|
AUC0-∞
Délai: 72 hours after dosing
|
area under the plasma concentration time curve from time zero to infinity of VV913
|
72 hours after dosing
|
|
AUC0-t
Délai: 72 hours after dosing
|
area under the plasma concentration time curve from time zero to the last of VV913
|
72 hours after dosing
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Huan Zhou, The First Affiliated Hospital of Anhui Medical University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 mai 2026
Achèvement primaire (Estimé)
31 décembre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
27 avril 2026
Première publication (Réel)
4 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- VV913-03
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .