MyelofibrosisPhase 1NCT06024915
A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
A Phase 1 study testing TQ05105 tablets, Itraconazole capsule and Rifampicin Capsule in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- TQ05105 tablets, Itraconazole capsule and Rifampicin Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2023to 6 May 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
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
- Being tested
- TQ05105 tablets, Itraconazole capsule, Rifampicin Capsule
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ05105 tabletsDrug
TQ05105 is a Janus kinase 2 (JAK2) inhibitor.
Itraconazole capsuleDrug
Itraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A).
Rifampicin CapsuleDrug
Rifampicin is a strong inducer of CYP3A.
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole drug-durg interaction (DDI) | Experimental | Itraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5. Receives: Drug: TQ05105 tablets; Drug: Itraconazole capsule |
| Rifampicin DDI | Experimental | Rifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9. Receives: Drug: TQ05105 tablets; Drug: Rifampicin Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Maximum plasma drug concentration after administration.
Measured: Up to 10 days.
Time to reach Cmax (Tmax)
Time to reach the maximum plasma concentration after administration.
Measured: Up to 10 days.
Elimination half-life (t1/2)
The elimination half-life (t1/2) after oral dose of TQ05105 tablets and Itraconazole capsule.
Measured: Up to 6 days.
Secondary outcomes (1)
Occurrence of adverse events (AE)
Including all adverse events (AE) and serious adverse events (SAE).
Measured: Up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start21 Sep 2023
- Primary completion29 Jan 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024915
- Sponsor's protocol ID
- TQ05105-I-04
- Status last verified
- Dec 2025
- First submitted
- 30 Aug 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No