Actively Recruiting
To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-04-06
24
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to voluntarily participate and sign informed consent
- No pregnancy or sperm/egg donation plans from screening until 6 months after last dose, and agree to use effective contraception
- Aged 18 to 75 years, any gender
- Male participants weigh at least 50 kg; female participants weigh at least 45 kg
- Body mass index (BMI) between 18.0 and 32.0 kg/m²
- Able to communicate and comply with study procedures
- For normal liver function group: negative tests for hepatitis B surface antigen and hepatitis C antibody
- Weight and age within 10 kg and 10 years, respectively, of liver impairment groups; similar gender distribution
- For impaired liver function: chronic liver injury from primary liver diseases or cirrhosis, Child-Pugh Grade A or B
- Stable condition within 2 weeks prior to dosing
- No medication within 4 weeks before screening or stable treatment for underlying diseases
You will not qualify if you...
- History or current severe/chronic diseases unsuitable for study (except primary liver diseases and related complications)
- Conditions affecting drug absorption or metabolism, such as swallowing difficulties or prior gastrointestinal surgery
- Use of strong/moderate CYP3A4, CYP2C9, or CYP2C19 inducers/inhibitors within 4 weeks before screening
- Known allergy to TQ05105 components or history of multiple allergies
- Smoking more than 5 cigarettes daily within 3 months before screening
- Drug abuse history or positive drug screen within 3 months
- Excessive alcohol use history: >2 units/day within 1 year for alcoholic liver disease, or within 3 months for others
- Blood donation or significant blood loss within 4 weeks before screening
- Consumption of alcohol, grapefruit juice, coffee, tea, cola, or chocolate within 48 hours before dosing
- Creatinine clearance below 60 mL/min
- Pregnant or breastfeeding women, positive pregnancy test, or unprotected sex within 2 weeks before screening
- Positive HIV or syphilis antibody tests
- Other investigator-determined unsuitability
- Additional exclusions for normal liver function: recent drug or supplement use, abnormal clinical tests, recent participation in other drug trials
- Additional exclusions for impaired liver function: history of liver transplant, hepatic coma, recent acute liver disease, biliary or cholestatic diseases, liver failure or cancer, recent serious liver complications, abnormal screening tests, massive ascites, recent investigational drug use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471000
Actively Recruiting
2
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, Shandong, China, 250000
Not Yet Recruiting
Research Team
W
Wei Zhao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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