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Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets

23 de julho de 2026 atualizado por: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Single-center, Open-label, Single-dose, Fixed-dose Regimen, Self-controlled Phase I Clinical Trial to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the pH-dependent Pharmacokinetics of TQ05105 Tablets

Primary objective:

To evaluate the effect of rabeprazole on the primary pharmacokinetics of TQ05105 tablets.

Secondary objective:

To assess the safety and tolerability of single oral administration of TQ05105 tablets alone and in combination with rabeprazole in healthy study participants.

To evaluate the effect of rabeprazole on the secondary PK parameters of TQ05105 and the pharmacokinetics of its active metabolite TQ12550.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Tipo de estudo

Intervencional

Inscrição (Real)

17

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Hunan
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital, Central South University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Signed informed consent prior to the study, fully understood the study content, procedures and potential adverse reactions; able to complete the study per protocol requirements.
  • The participant (including partner) agrees not to plan pregnancy, sperm donation or egg donation from screening until 6 months after the last study drug administration, and is willing to use effective contraception.
  • Healthy male and female participants aged 18-45 years (inclusive).
  • Male body weight ≥ 50.0 kg; female body weight ≥ 45.0 kg.BMI = weight (kg)/height² (m²), range 18.0-28.0 kg/m² (inclusive).

Exclusion Criteria:

  • Participants with clinically significant abnormalities in vital signs, physical examination, ECG or clinical laboratory tests, and deemed unsuitable for participation by the investigator.
  • Participants with severe or chronic diseases of the circulatory, digestive, respiratory, urinary, nervous, hematologic, endocrine/metabolic, neoplastic, immune or psychiatric systems within the past 1 year or currently, or any other disease that may interfere with study results.
  • Platelet count or absolute neutrophil count below the lower limit of the reference range at screening.
  • Any disease increasing bleeding risk, such as hemorrhoids, acute gastritis, gastric or duodenal ulcer.
  • Alanine aminotransferase (ALT) > 1.2×ULN, aspartate aminotransferase (AST) > 1.2×ULN, alkaline phosphatase (ALP) > 1.2×ULN, total bilirubin (TBIL) > 1.2×ULN, or any clinically significant abnormality judged by the investigator.
  • Any malignancy within the past 5 years.
  • Any condition that may affect absorption, distribution, metabolism or excretion of study drug (e.g., inability to swallow), or history of gastrointestinal resection that may affect drug disposition.
  • Allergy to rabeprazole, TQ05105 or their excipients; or history of multiple allergies (≥2 substances), including drug allergy, and tendency to develop rash, eczema, urticaria, asthma, etc.
  • Use of any strong or moderate inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C19 within 4 weeks prior to screening.
  • Use of any prescription drugs, over the counter medications, herbal medicines or dietary supplements (e.g., vitamins, calcium supplements) within 4 weeks prior to screening.
  • Use of any acid suppressive therapy within 3 months prior to screening.
  • Participation in any clinical trial involving investigational drugs within 3 months prior to screening or within 5 half lives of the study drug (whichever is longer).
  • Positive results for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or syphilis antibody.
  • Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m² at screening.
  • Average daily cigarette consumption >5 cigarettes within 3 months prior to screening.
  • History of drug abuse within 3 months prior to screening, or positive urine drug screen.
  • Regular alcohol consumption within 3 months prior to screening (≥14 units/week; 1 unit = 360 mL beer / 45 mL 40% spirits / 150 mL wine), or positive alcohol breath test.
  • Blood donation or blood loss ≥200 mL, or plasma exchange within 4 weeks prior to screening.
  • Consumption of alcohol (or positive alcohol breath test), grapefruit juice, coffee, tea, cola, chocolate or related food/beverage within 72 hours before dosing.
  • Pregnant or breastfeeding female participants, positive serum pregnancy test, or unprotected sexual intercourse within 2 weeks prior to screening for women of childbearing potential.
  • Strenuous exercise (e.g., marathon, weightlifting) within 2 weeks prior to screening.
  • Any other condition deemed unsuitable for participation by the investigator.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: TQ05105 tablets
TQ05105 tablets combined with rabeprazole sodium enteric-coated tablets, 14 days as a treatment cycle.
TQ05105 tablets are Janus kinase (JAK) inhibitors.
Rabeprazole sodium enteric-coated tablets.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Peak concentration (Cmax)
Prazo: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Maximum plasma drug concentration.
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Area under the plasma concentration-time curve ( AUC0-t)
Prazo: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
The area enclosed by the blood concentration curve to the timeline.
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Maximum concentration (Tmax)
Prazo: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
The time required to reach peak concentration after administration.
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Plasma clearance (CL/F)
Prazo: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
How much of the plasma is cleared per unit of time.
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Plasma elimination half-life (t1/2)
Prazo: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
The time it takes for the terminal phase blood concentration to drop by half.
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Area under the plasma concentration-time curve ( AUC0-∞)
Prazo: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
The area enclosed by the blood concentration curve to the timeline.
1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Adverse event rate
Prazo: 14 days after the first dose
The occurrence of all adverse events (AEs), and serious adverse events (SAEs).
14 days after the first dose
Hematology
Prazo: 14 days after the first dose
Abnormal hematology
14 days after the first dose
Serum biochemistry
Prazo: 14 days after the first dose
Abnormal serum biochemistry
14 days after the first dose
Coagulation
Prazo: 14 days after the first dose
Abnormal coagulation
14 days after the first dose
Urinalysis
Prazo: 14 days after the first dose
Abnormal urinalysis
14 days after the first dose
Blood pressure
Prazo: 14 days after the first dose
Abnormal blood pressure
14 days after the first dose
Pulse
Prazo: 14 days after the first dose
Abnormal pulse
14 days after the first dose
Respiration
Prazo: 14 days after the first dose
Abnormal respiration
14 days after the first dose
Body temperature
Prazo: 14 days after the first dose
Abnormal body temperature
14 days after the first dose
12-lead ECG
Prazo: 14 days after the first dose
Abnormal 12-lead ECG
14 days after the first dose
Physical examination
Prazo: 14 days after the first dose
Abnormal physical examination
14 days after the first dose
Symptoms
Prazo: 14 days after the first dose
Abnormal symptoms
14 days after the first dose

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de julho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

20 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de maio de 2026

Primeira postagem (Real)

27 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • TQ05105-I-09

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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