Aún no reclutaNCT07927218Registro de ClinicalTrials.gov

Study of Food Effects of VV261 Tablets in Healthy Trial Participants

Severe Fever With Thrombocytopenia Syndrome

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 1
Rango de edad: 18 años - 45 años
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 15 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

A group

No informado en este registro.

Drug: VV261

B group

No informado en este registro.

Drug: VV261

C group

No informado en este registro.

Drug: VV261

VV261 DRUG

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;

VV261 DRUG

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;

VV261 DRUG

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 ;

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