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

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

17

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Peak concentration (Cmax)
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum concentration (Tmax)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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-∞)
Tidsram: 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
Tidsram: 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
Tidsram: 14 days after the first dose
Abnormal hematology
14 days after the first dose
Serum biochemistry
Tidsram: 14 days after the first dose
Abnormal serum biochemistry
14 days after the first dose
Coagulation
Tidsram: 14 days after the first dose
Abnormal coagulation
14 days after the first dose
Urinalysis
Tidsram: 14 days after the first dose
Abnormal urinalysis
14 days after the first dose
Blood pressure
Tidsram: 14 days after the first dose
Abnormal blood pressure
14 days after the first dose
Pulse
Tidsram: 14 days after the first dose
Abnormal pulse
14 days after the first dose
Respiration
Tidsram: 14 days after the first dose
Abnormal respiration
14 days after the first dose
Body temperature
Tidsram: 14 days after the first dose
Abnormal body temperature
14 days after the first dose
12-lead ECG
Tidsram: 14 days after the first dose
Abnormal 12-lead ECG
14 days after the first dose
Physical examination
Tidsram: 14 days after the first dose
Abnormal physical examination
14 days after the first dose
Symptoms
Tidsram: 14 days after the first dose
Abnormal symptoms
14 days after the first dose

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 juli 2026

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

20 maj 2026

Först inskickad som uppfyllde QC-kriterierna

20 maj 2026

Första postat (Faktisk)

27 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • TQ05105-I-09

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