A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets

NCT ID: NCT06024915

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-05-06

Brief Summary

This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of metabolic enzyme inhibitors/inducers on in vivo metabolic and elimination of TQ05105 tablets, and the safety of metabolic enzyme inhibitors/inducers combined with TQ05105 tablets.

Conditions

Myelofibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Itraconazole drug-durg interaction (DDI)

Itraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5.

Group Type: EXPERIMENTAL

TQ05105 tablets

Intervention Type: DRUG

TQ05105 is a Janus kinase 2 (JAK2) inhibitor.

Itraconazole capsule

Intervention Type: DRUG

Itraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A).

Rifampicin DDI

Rifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9.

Group Type: EXPERIMENTAL

TQ05105 tablets

Intervention Type: DRUG

TQ05105 is a Janus kinase 2 (JAK2) inhibitor.

Rifampicin Capsule

Intervention Type: DRUG

Rifampicin is a strong inducer of CYP3A.

Interventions

TQ05105 tablets

TQ05105 is a Janus kinase 2 (JAK2) inhibitor.

Intervention Type: DRUG

Itraconazole capsule

Itraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A).

Intervention Type: DRUG

Rifampicin Capsule

Rifampicin is a strong inducer of CYP3A.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• At the time of signing the informed consent, males or females between 18 and 45 years of age;
• Female weight ≥ 45 kg, male weight ≥ 50 kg, with a body mass index (BMI) between 19 and 26 kg/m2.
• Subjects in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations;
• Subjects can comply with the study procedures, voluntarily participate in the study, and sign the informed consent in person.

Exclusion Criteria

• Subjects: preexisting or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders or abnormalities, or related chronic or acute diseases, the investigator assesses that it is not appropriate to participate in the trial；
• Subjects with Systemic/local acute infection before taking the study drug;
• Subjects who have a history of specific allergies, or allergic conditions (such as allergies to two or more drugs, environments, or foods), or are known to be allergic to components or analogs of the study drug;
• Subjects who have difficulty in swallowing or have any gastrointestinal disorder that affects drug absorption at the time of screening；
• Subjects who cannot receive venous indwelling needle for blood sample collection；
• Subjects who drank regularly in the 6 months prior to first dosing, such as those who drank more than 14 units of alcohol per week or who had a positive alcohol breath test at the time of screening；
• Subjects who had a history of major surgery, or had taken the study drug, or had participated in other drug clinical trials within 3 months prior to initial dosing；
• Subjects who donated blood or lost significant amounts of blood within 3 months prior to initial dosing；
• Subjects who had used drugs within 3 months prior to first dosing, or tested positive for drugs, or had a history of drug abuse within 5 years prior to screening；
• Subjects who smoked more than 5 cigarettes per day in the 3 months prior to initial dosing or who could not stop using any tobacco products during the trial；
• Subjects who consumed excessive amounts of tea, coffee, and/or caffeinated beverages daily in the 30 days prior to initial dosing；
• Subjects who have used any drug that inhibits or induces liver metabolism of the drug in the 30 days prior to initial dosing；
• Subjects who have taken any prescription, over-the-counter, herbal, or health product in the 14 days prior to initial dosing；
• Subjects who have taken a special diet or other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to initial dosing；
• Subjects who ingested chocolate, any caffeinated, or xanthine-rich food or drink 48 hours before first dosing；
• Subjects who have special dietary requirements and cannot follow a uniform diet；
• Female subjects of child-bearing potential；
• Subjects judged by the investigator to be unsuitable to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong Provincial Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

TQ05105-I-04

Identifier Type: -

Identifier Source: org_study_id