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

NCT07608666 | Active Not Recruiting Phase 1

• 1 other identifier: TQ05105-I-09
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. To evaluate the effect of rabeprazole on the secondary PK parameters of TQ05105 and the pharmacokinetics of its active metabolite TQ12550.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Maximum concentration (Tmax)

  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)

  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)

  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-∞)

  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

  14 days after the first dose

Study Arms (1)

TQ05105 tablets

OTHER

TQ05105 tablets combined with rabeprazole sodium enteric-coated tablets, 14 days as a treatment cycle.

Drug: TQ05105 tablets; Drug: Rabeprazole sodium enteric-coated tablets

Interventions

TQ05105 tablets DRUG

TQ05105 tablets are Janus kinase (JAK) inhibitors.

TQ05105 tablets

Rabeprazole sodium enteric-coated tablets DRUG

Rabeprazole sodium enteric-coated tablets.

TQ05105 tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Third Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-06

Locations

CN (1)