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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
- ClinicalTrials.gov ID
- NCT06024915
- Acronym / sponsor ID
- TQ05105-I-04
- Conditions
- Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole drug-durg interaction (DDI) | Experimental | Drug: TQ05105 tablets, Drug: Itraconazole capsuleItraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5. |
| Rifampicin DDI | Experimental | Drug: TQ05105 tablets, Drug: Rifampicin CapsuleRifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQ05105 tabletsTQ05105 is a Janus kinase 2 (JAK2) inhibitor. | Drug | Itraconazole drug-durg interaction (DDI), Rifampicin DDI |
| Itraconazole capsuleItraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A). | Drug | Itraconazole drug-durg interaction (DDI) |
| Rifampicin CapsuleRifampicin is a strong inducer of CYP3A. | Drug | Rifampicin DDI |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: Up to 10 days.
Maximum plasma drug concentration after administration.
Time to reach Cmax (Tmax)
Time frame: Up to 10 days.
Time to reach the maximum plasma concentration after administration.
Elimination half-life (t1/2)
Time frame: Up to 6 days.
The elimination half-life (t1/2) after oral dose of TQ05105 tablets and Itraconazole capsule.
1 secondary outcome
Occurrence of adverse events (AE)
Time frame: Up to 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: Up to 10 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.