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

NCT07480824 | Not Yet Recruiting Phase 1

• 1 other identifier: TQ05105-I-08
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (2)

• Peak concentration (Cmax)

  Maximum plasma drug concentration of TQ05105 and TQ12550

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

• Area under the concentration-time curve (AUC)

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

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

Secondary Outcomes (8)

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

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

• Plasma half life (t1/2)

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

• Apparent volume of distribution (Vz/F)

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

• Terminal elimination rate (λz)

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

• Curve extrapolated to infinity (AUC_%Extrap)

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

Study Arms (3)

A: Mild hepatic impairment (Child-Pugh A)

ACTIVE COMPARATOR

A: 15 mg orally , single dose

Drug: TQ05105

B: Moderate hepatic impairment (Child-Pugh B)

ACTIVE COMPARATOR

B: 10 mg orally , single dose

Drug: TQ05105

C: Normal

ACTIVE COMPARATOR

C: 15 mg orally , single dose

Drug: TQ05105

Interventions

TQ05105 DRUG

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

A: Mild hepatic impairment (Child-Pugh A); B: Moderate hepatic impairment (Child-Pugh B); C: Normal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, 471000, China

Location

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wei Zhao, Doctor

CONTACT

0531-85875449; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-02

Locations

CN (2)