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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myelofibrosis
• Intervention / Treatment: Drug: TQ05105 tablets; Drug: Rabeprazole sodium enteric-coated tablets

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guoping Yang, Doctor; Phone Number: 0731-89918665; Email: ygp9880@163.com
• Study Contact Backup: Name: Xiaocong Zuo, Doctor; Phone Number: 13808466377; Email: zuoxc08@126.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital, Central South University
      • Contact: Guoping Yang, Doctor; Phone Number: 0731-89918665; Email: ygp9880@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TQ05105 tablets; TQ05105 tablets combined with rabeprazole sodium enteric-coated tablets, 14 days as a treatment cycle.	Drug: TQ05105 tablets; TQ05105 tablets are Janus kinase (JAK) inhibitors.; Drug: Rabeprazole sodium enteric-coated tablets; Rabeprazole sodium enteric-coated tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax)	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Tmax)	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)	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)	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-∞)	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	The occurrence of all adverse events (AEs), and serious adverse events (SAEs).	14 days after the first dose
Hematology	Abnormal hematology	14 days after the first dose
Serum biochemistry	Abnormal serum biochemistry	14 days after the first dose
Coagulation	Abnormal coagulation	14 days after the first dose
Urinalysis	Abnormal urinalysis	14 days after the first dose
Blood pressure	Abnormal blood pressure	14 days after the first dose
Pulse	Abnormal pulse	14 days after the first dose
Respiration	Abnormal respiration	14 days after the first dose
Body temperature	Abnormal body temperature	14 days after the first dose
12-lead ECG	Abnormal 12-lead ECG	14 days after the first dose
Physical examination	Abnormal physical examination	14 days after the first dose
Symptoms	Abnormal symptoms	14 days after the first dose

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Hemic and Lymphatic Diseases; Primary Myelofibrosis
• Other Study ID Numbers: TQ05105-I-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No