- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608666
Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets
20. maj 2026 opdateret af: 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 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
16
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Guoping Yang, Doctor
- Telefonnummer: 0731-89918665
- E-mail: ygp9880@163.com
Undersøgelse Kontakt Backup
- Navn: Xiaocong Zuo, Doctor
- Telefonnummer: 13808466377
- E-mail: zuoxc08@126.com
Studiesteder
-
-
Hunan
-
Changsha, Hunan, Kina, 410013
- The Third Xiangya Hospital, Central South University
-
Kontakt:
- Guoping Yang, Doctor
- Telefonnummer: 0731-89918665
- E-mail: ygp9880@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak concentration (Cmax)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum concentration (Tmax)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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-∞)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 14 days after the first dose
|
Abnormal hematology
|
14 days after the first dose
|
|
Serum biochemistry
Tidsramme: 14 days after the first dose
|
Abnormal serum biochemistry
|
14 days after the first dose
|
|
Coagulation
Tidsramme: 14 days after the first dose
|
Abnormal coagulation
|
14 days after the first dose
|
|
Urinalysis
Tidsramme: 14 days after the first dose
|
Abnormal urinalysis
|
14 days after the first dose
|
|
Blood pressure
Tidsramme: 14 days after the first dose
|
Abnormal blood pressure
|
14 days after the first dose
|
|
Pulse
Tidsramme: 14 days after the first dose
|
Abnormal pulse
|
14 days after the first dose
|
|
Respiration
Tidsramme: 14 days after the first dose
|
Abnormal respiration
|
14 days after the first dose
|
|
Body temperature
Tidsramme: 14 days after the first dose
|
Abnormal body temperature
|
14 days after the first dose
|
|
12-lead ECG
Tidsramme: 14 days after the first dose
|
Abnormal 12-lead ECG
|
14 days after the first dose
|
|
Physical examination
Tidsramme: 14 days after the first dose
|
Abnormal physical examination
|
14 days after the first dose
|
|
Symptoms
Tidsramme: 14 days after the first dose
|
Abnormal symptoms
|
14 days after the first dose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
20. maj 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TQ05105-I-09
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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