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Active, not recruitingNCT07608666Updated Jul 27, 2026

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

A Phase 1 interventional study of TQ05105 tablets and Rabeprazole sodium enteric-coated tablets in Myelofibrosis, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myelofibrosis

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03

In context

Primary Myelofibrosis

419 studies on the registry are indexed under Primary Myelofibrosis; 117 are open to participants now.

This study's enrollment of 17 is below the median of 44 across 347 interventional studies indexed under Primary Myelofibrosis.

Browse Primary Myelofibrosis studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Other
    TQ05105 tablets

    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

  • DrugTQ05105 tablets

    TQ05105 tablets are Janus kinase (JAK) inhibitors.

  • DrugRabeprazole sodium enteric-coated tablets

    Rabeprazole sodium enteric-coated tablets.

06

What researchers measure

Primary outcomes

  1. Peak concentration (Cmax)

    Maximum plasma drug concentration.

    Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  2. Area under the plasma concentration-time curve ( AUC0-t)

    The area enclosed by the blood concentration curve to the timeline.

    Time frame: 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

  1. Maximum concentration (Tmax)

    The time required to reach peak concentration after administration.

    Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  2. Plasma clearance (CL/F)

    How much of the plasma is cleared per unit of time.

    Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  3. Plasma elimination half-life (t1/2)

    The time it takes for the terminal phase blood concentration to drop by half.

    Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  4. Area under the plasma concentration-time curve ( AUC0-∞)

    The area enclosed by the blood concentration curve to the timeline.

    Time frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  5. Adverse event rate

    The occurrence of all adverse events (AEs), and serious adverse events (SAEs).

    Time frame: 14 days after the first dose

  6. Hematology

    Abnormal hematology

    Time frame: 14 days after the first dose

  7. Serum biochemistry

    Abnormal serum biochemistry

    Time frame: 14 days after the first dose

  8. Coagulation

    Abnormal coagulation

    Time frame: 14 days after the first dose

  9. Urinalysis

    Abnormal urinalysis

    Time frame: 14 days after the first dose

  10. Blood pressure

    Abnormal blood pressure

    Time frame: 14 days after the first dose

  11. Pulse

    Abnormal pulse

    Time frame: 14 days after the first dose

  12. Respiration

    Abnormal respiration

    Time frame: 14 days after the first dose

  13. Body temperature

    Abnormal body temperature

    Time frame: 14 days after the first dose

  14. 12-lead ECG

    Abnormal 12-lead ECG

    Time frame: 14 days after the first dose

  15. Physical examination

    Abnormal physical examination

    Time frame: 14 days after the first dose

  16. Symptoms

    Abnormal symptoms

    Time frame: 14 days after the first dose

07

Study locations

1 site
  • The Third Xiangya Hospital, Central South University
    Changsha, Hunan 410013, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07608666
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Jul 20, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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