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AzTrials

MyelofibrosisPhase 1NCT05982106

To Evaluate the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects

A Phase 1 study testing TQ05105 Tablets in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 （JAK2）inhibitor and can be used to treat JAK2 target-related diseases. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Myelofibrosis
What is being tested?
TQ05105 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
19 Jul 2021to 28 Jul 2021
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1 Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions;
  • 2 Able to communicate well, understand and complete the research in accordance with the requirements of the experimental protocol;
  • 3 Male and female subjects aged 18 to 65 (including 18 and 65 years old);
  • 4 Body mass index (BMI) ≥ 18 and ≤ 28kg/m2, and male weight ≥ 50 kg and female weight ≥ 45 kg;
  • 5 Health status: no history of heart, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities, and physical examination showed normal or abnormal blood pressure, heart rate, electrocardiogram, respiratory system, liver, kidney function and blood picture without clinical significance;
  • 6 The subjects have no pregnancy plans and voluntarily take effective contraceptive measures from 2 weeks before the administration to at least 6 months after the last use of the study drug.

Who cannot join

  • 1 Patients with neuropsychiatric system, respiratory system, cardiovascular system, digestive tract system, blood-lymphatic system, liver and kidney insufficiency, endocrine system, musculoskeletal system disease or other diseases in the past, and the researcher judges that the past medical history may have an adverse effect on the drug. Metabolic or safety effects;
  • 2 Those with allergic constitution or a history of two or more food or drug allergies in the past;
  • 3 Those with multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal diseases);
  • 4 Taking any prescription, over-the-counter, vitamin product or herbal medicine within 1 month before taking the study drug;
  • 5 Take CYP3A4 inhibitors or inducers within 1 month before screening or before study medication;
  • 6 Those who have taken special diets (including grapefruit, etc.) or exercised vigorously within 14 days before screening, or have other factors that affect drug absorption, distribution, metabolism, and excretion;
Show all 16Show fewer
  • 7 aboratory examinations during the screening period are abnormal and have clinical significance;
  • 8 Blood donation or massive blood loss (> 450mL) within 3 months before taking the study drug;
  • 9 Participated in any drug clinical trial within 3 months before taking the study drug;
  • 10 Smoking more than 5 cigarettes per day within 3 months before the test;
  • 11 Positive breath test for alcohol or a history of alcohol abuse within 2 weeks before screening (drinking 14 units of alcohol per week: 1 unit = 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine);
  • 12 Those who are positive for drug screening or have used drugs in the 3 months before the test;
  • 13 Inability to tolerate venipuncture for blood collection or poor vascular condition;
  • 14 Subjects have a history of herpes zoster within 1 month before screening;
  • 15 The subject is unable to complete the trial due to personal reasons;
  • 16 Other investigators deem it unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

    Changchun, Jilin, 130103

Other trials in China

About this study

Official title: A Randomized, Open-label, Single-center, Two-cycle, Two-crossover Phase I Clinical Trial Evaluating the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects

TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 （JAK2）inhibitor and can be used to treat JAK2 target-related diseases. This study is a randomized, open-label, single-center, two-cycle, two-crossover Phase I clinical trial evaluating the effect of food on the pharmacokinetics of TQ05105 tablets in healthy adult subjects. Pharmacokinetic effects and safety after oral administration of TQ05105 tablets.

Conditions
Myelofibrosis
Being tested
TQ05105 Tablets
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 tablet is a novel JAK2 inhibitor.

Study groups in NCT05982106
Study groupRoleWhat they receive
TQ05105 Tablets (fasted)ExperimentalTQ05105 tablets was administered on fasted state in the first cycle for Group A and the second cycle for Group B.
Receives: Drug: TQ05105 Tablets
TQ05105 Tablets (fed)ExperimentalTQ05105 tablets was administered on fed state in the second cycle for Group A and the first cycle for Group B.
Receives: Drug: TQ05105 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the drug-time curve (AUC)

    Area under the drug-time curve

    Measured: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration

  2. Maximum Concentration (Cmax)

    Maximum concentration

    Measured: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration

Secondary outcomes (8)

  1. Time to maximum concentration following drug administration (Tmax)

    Time to maximum concentration following drug administration

    Measured: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration

  2. Apparent terminal elimination half-life following drug administration (t1/2)

    Apparent terminal elimination half-life following drug administration

    Measured: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration

  3. Apparent volume of distribution (Vd/F)

    Apparent volume of distribution

    Measured: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration

  4. Clearance rate (CL/F)

    Clearance rate

    Measured: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration

  5. Adverse event rate

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Measured: Baseline up to 24 hours after administration

  6. Body temperature

    Monitor the safety indicators of subjects during the trial

    Measured: 1 hour before administration and 1, 4, 12, 24 hours after administration

  7. Pulse

    Monitor the safety indicators of subjects during the trial

    Measured: 1 hour before administration and 1, 4, 12, 24 hours after administration

  8. Blood pressure

    Monitor the safety indicators of subjects during the trial

    Measured: 1 hour before administration and 1, 4, 12, 24 hours after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start19 Jul 2021
  3. Primary completion28 Jul 2021
  4. Study completion28 Jul 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982106
Sponsor's protocol ID
TQ05105-I-03
Status last verified
Aug 2023
First submitted
7 Jul 2023
Last updated
8 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dai J, Cheng Y, Zhou Y, Wang Y, Liu Z, Ren Q, Su Z, Deng Q, Yang H, Cui Y. Food effect trial of the pharmacokinetics and safety of TQ05105 in healthy Chinese subjects. Cancer Chemother Pharmacol. 2025 Feb 10;95(1):31. doi: 10.1007/s00280-025-04754-z.

    PubMed 39924599

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQ05105 Tablets 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 6 inclusion and 16 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 8 Aug 2023. 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?

Area under the drug-time curve (AUC) (time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05982106, which also lists 1 linked publication.

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 8 Aug 2023.

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