MyelofibrosisPhase 1NCT07608666
Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets
A Phase 1 study testing TQ05105 tablets and Rabeprazole sodium enteric-coated tablets in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- TQ05105 tablets and Rabeprazole sodium enteric-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital, Central South University
Changsha, Hunan, 410013
About this study
Official title: 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.
- Conditions
- Myelofibrosis
- Being tested
- TQ05105 tablets, Rabeprazole sodium enteric-coated tablets
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ05105 tabletsDrug
TQ05105 tablets are Janus kinase (JAK) inhibitors.
Rabeprazole sodium enteric-coated tabletsDrug
Rabeprazole sodium enteric-coated tablets.
| Study group | Role | What they receive |
|---|---|---|
| TQ05105 tablets | Other | TQ05105 tablets combined with rabeprazole sodium enteric-coated tablets, 14 days as a treatment cycle. Receives: Drug: TQ05105 tablets; Drug: Rabeprazole sodium enteric-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Maximum plasma drug concentration.
Measured: 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)
The area enclosed by the blood concentration curve to the timeline.
Measured: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Secondary outcomes (16)
Maximum concentration (Tmax)
The time required to reach peak concentration after administration.
Measured: 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)
How much of the plasma is cleared per unit of time.
Measured: 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)
The time it takes for the terminal phase blood concentration to drop by half.
Measured: 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-∞)
The area enclosed by the blood concentration curve to the timeline.
Measured: 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
The occurrence of all adverse events (AEs), and serious adverse events (SAEs).
Measured: 14 days after the first dose
Hematology
Abnormal hematology
Measured: 14 days after the first dose
Serum biochemistry
Abnormal serum biochemistry
Measured: 14 days after the first dose
Coagulation
Abnormal coagulation
Measured: 14 days after the first dose
Urinalysis
Abnormal urinalysis
Measured: 14 days after the first dose
Blood pressure
Abnormal blood pressure
Measured: 14 days after the first dose
Pulse
Abnormal pulse
Measured: 14 days after the first dose
Respiration
Abnormal respiration
Measured: 14 days after the first dose
Body temperature
Abnormal body temperature
Measured: 14 days after the first dose
12-lead ECG
Abnormal 12-lead ECG
Measured: 14 days after the first dose
Physical examination
Abnormal physical examination
Measured: 14 days after the first dose
Symptoms
Abnormal symptoms
Measured: 14 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start20 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608666
- Sponsor's protocol ID
- TQ05105-I-09
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No