CClinicalTrials.gg
RecruitingNCT07480824Updated Apr 6, 2026

To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects

A Phase 1 interventional study of TQ05105 in Myelofibrosis, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.

02

Conditions studied

  • Myelofibrosis

Browse trials for

03

In context

Primary Myelofibrosis

419 studies on the registry are indexed under Primary Myelofibrosis; 116 are open to participants now.

This study's planned enrollment of 24 is below the median of 44 across 347 interventional studies indexed under Primary Myelofibrosis.

Browse Primary Myelofibrosis studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Voluntarily participate in the clinical trial and sign the informed consent form, with full understanding of the trial content, procedures, and potential adverse reactions.
  • Patients (including partners) have no pregnancy plans or sperm/egg donation plans from screening until 6 months after the last dose of the investigational drug, and agree to use effective contraception.
  • Aged 18-75 years (inclusive), regardless of gender.
  • Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body mass index (BMI) = weight (kg)/height² (m²), with BMI ranging 18.0-32.0 kg/m² (inclusive).
  • Patients can communicate effectively with investigators and comply with the trial protocol.

Additional Criteria for Participants with Normal Liver Function:

  • Negative serum HBsAg and Hepatitis C Virus (HCV) antibody test results.
  • Weight within ±10 kg of the average weight of groups A/B; age within ±10 years of the average age of groups A/B; gender distribution similar to groups A/B (±1 participant per gender).

Additional Criteria for Participants with Impaired Liver Function:

  • Chronic liver injury caused by primary liver diseases (e.g., hepatitis B/C, non-alcoholic fatty liver disease, alcoholic liver disease) or clinically diagnosed cirrhosis, classified as Child-Pugh Grade A or B.
  • Stable condition within 2 weeks prior to dosing as judged by the investigator.
  • No medication within 4 weeks before screening, or stable treatment regimen for underlying diseases (including liver-protective therapy).

Exclusion criteria

Exclusion Criteria:

  • History or current diagnosis of severe/chronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine, oncological, immunological, or psychiatric disorders) deemed unsuitable by the investigator (except primary liver diseases and complications in participants with impaired liver function).
  • Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., dysphagia) or prior gastrointestinal resection impacting these processes.
  • Use of strong/moderate CYP3A4, CYP2C9, or CYP2C19 inducers/inhibitors within 4 weeks before screening.
  • Known hypersensitivity to TQ05105 tablet components or allergic constitution (e.g., allergy to ≥2 substances, drug allergy history, or prone to rash/eczema/asthma).
  • Average daily smoking >5 cigarettes within 3 months before screening.
  • Drug abuse history or positive urine drug screen within 3 months.
  • For alcoholic liver disease participants: history of excessive drinking (>2 alcohol units/day) within 1 year; for others: such history within 3 months.
  • Blood donation/loss ≥200 mL or plasmapheresis within 4 weeks before screening.
  • Consumption of alcohol (or positive breath test), grapefruit juice, coffee, tea, cola, or chocolate within 48 hours before dosing.
  • Creatinine clearance (CLcr) \<60 mL/min.
  • Pregnant/lactating women, positive pregnancy test, or unprotected sex within 2 weeks before screening.
  • Positive HIV antibody or Treponema pallidum-specific antibody.
  • Other factors deemed unsuitable by the investigator.

Additional Exclusions for Normal Liver Function Participants:

  • Use of prescription/non-prescription drugs, herbal medicines, or supplements (e.g., vitamins) within 2 weeks before screening.
  • The results of physical examination during the screening period, vital signs, clinical laboratory tests (blood cell analysis (five categories), blood biochemistry, coagulation function, urine routine examination with sediment), electrocardiogram, frontal and lateral chest X-rays, abdominal ultrasound (liver, gallbladder, pancreas, spleen), and urinary system ultrasound, etc., which showed abnormal results and were determined by the research doctor to have clinical significance.
  • Patients in other drug trials within 3 months or 5 half-lives (whichever longer) before screening.

Additional Exclusions for Impaired Liver Function Participants:

  • Had a history of liver transplantation;
  • Patients with hepatic coma within 30 days before screening;
  • Patients who had used drugs that might cause acute hepatotoxicity (such as halothane and methotrexate) within 3 months before screening;
  • Patients with acute liver disease caused by drug or viral infection within 2 months before screening;
  • With biliary cirrhosis, liver/bile duct obstruction, cholestatic liver disease and other diseases affecting biliary excretion;
  • Patients with liver failure or liver cancer, or patients with a history of esophagogastric variceal bleeding, hepatic encephalopathy, severe portal hypertension, or a portasystemic shunt within 1 year before screening who were judged by the investigator to be ineligible for the trial;
  • Patients with abnormal physical examination, vital signs, clinical laboratory tests (blood cell analysis (five classification), blood biochemistry, coagulation function, urine routine and sediment), AFP, electrocardiogram, chest X-ray, echocardiography, abdominal ultrasound (liver, gallbladder, pancreas and spleen), urinary ultrasound, and routine electroencephalogram (EEG) during the screening period and judged by the research doctors as not suitable for the study;
  • Patients with massive ascites on ultrasound during the screening period who were assessed by the investigators as not suitable for the trial;
  • Who participated in and used any investigational drug within 1 month before screening.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    A: Mild hepatic impairment (Child-Pugh A)

    A: 15 mg orally , single dose

    Drug: TQ05105

  • Active comparator
    B: Moderate hepatic impairment (Child-Pugh B)

    B: 10 mg orally , single dose

    Drug: TQ05105

  • Active comparator
    C: Normal

    C: 15 mg orally , single dose

    Drug: TQ05105

Interventions

  • DrugTQ05105

    Janus Kinase Inhibitors/Rho-associated Kinase (JAK/ROCK) inhibitors

06

What researchers measure

Primary outcomes

  1. Peak concentration (Cmax)

    Maximum plasma drug concentration of TQ05105 and TQ12550

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration

  2. Area under the concentration-time curve (AUC)

    Area under the plasma concentration-time curve of TQ05105 and TQ12550

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration

Secondary outcomes

  1. Time-to-maximum concentration( Tmax) of TQ05105 and TQ12550

    Time-to-maximum concentration

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration

  2. Plasma half life (t1/2)

    The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half of TQ05105 and TQ12550

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration

  3. Apparent volume of distribution (Vz/F)

    Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration

  4. Terminal elimination rate (λz)

    First-order rate constant associated with the terminal (log-linear) elimination phase of TQ05105 and TQ12550

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  5. Curve extrapolated to infinity (AUC_%Extrap)

    Percentage of the Area Under the Curve extrapolated to infinity

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  6. Apparent Clearance (CL/F)

    The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability

    Time frame: Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration

  7. Fraction unbound(fu%)

    The proportion of a drug or substance in the bloodstream that is not bound to plasma proteins and is therefore free to exert pharmacological activity, be metabolized, or undergo elimination.

    Time frame: 0.5, 2, 6 hours after administration

  8. Adverse event rate

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

    Time frame: Baseline up to day7

07

Study locations

1 of 2 sites recruiting
  • The First Affiliated Hospital of Henan University of Science & Technology
    Luoyang, Henan 471000, China
    Recruiting
  • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
    Jinan, Shandong 250000, China
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07480824
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Mar 18, 2026
Start date
Apr 1, 2026
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 6, 2026

Study contacts

Wei Zhao, Doctor
Contact
zhao4wei2@hotmail.com
0531-85875449

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion