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

ConditionMyelofibrosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TQ05105 tablets
  • Rabeprazole sodium enteric-coated tablets

Treatment groups

17 Participants
are divided into 1 treatment group