NCT07608666Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 20 May 2026
- Start date
- 20 Jul 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT07608666
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 17
- From 20 Jul 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any strong or moderate inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C19 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).
- 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.
- Strenuous exercise (e.g., marathon, weightlifting) within 2 weeks prior to screening.
Other illness
- 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.
- Any disease increasing bleeding risk, such as hemorrhoids, acute gastritis, gastric or duodenal ulcer.
- 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.
- Positive results for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or syphilis antibody.
- Any other condition deemed unsuitable for participation by the investigator.
Lab values
- Participants with clinically significant abnormalities in vital signs, physical examination, ECG or clinical laboratory tests, and deemed unsuitable for participation by the investigator.
- Platelet count or absolute neutrophil count below the lower limit of the reference range at screening.
- 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.
- 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.
- Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m² at screening.
- Pregnant or breastfeeding female participants, positive serum pregnancy test, or unprotected sexual intercourse within 2 weeks prior to screening for women of childbearing potential.
Other
- Consumption of alcohol (or positive alcohol breath test), grapefruit juice, coffee, tea, cola, chocolate or related food/beverage within 72 hours before dosing.
Who the study is looking for
- 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).
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.