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Tests treatment safety and results for Myelofibrosis
Official title To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects
ClinicalTrials.gov ID: NCT07480824
What this study is testing
What is TQ05105?
TQ05105 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Voluntarily participate in the clinical trial and sign the informed consent form, with full understanding of the trial content, procedures, and...
- Patients (including partners) have no pregnancy plans or sperm/egg donation plans from screening until 6 months after the last dose of the...
- 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...
- Patients can communicate effectively with investigators and comply with the trial protocol. Additional Criteria for Participants with Normal Liver...
You likely can't join if
- History or current diagnosis of severe/chronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine...
- Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., dysphagia) or prior gastrointestinal resection impacting these...
- 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...
- Average daily smoking \>5 cigarettes within 3 months before screening.
- Drug abuse history or positive urine drug screen within 3 months.
See the full eligibility criteria
Who can join
- 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...
- 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).
What rules you out
- History or current diagnosis of severe/chronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine, oncological, immunological, or psychiatric disorders) deemed unsuitable by...
- 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...
- 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...
- Patients with abnormal physical examination, vital signs, clinical laboratory tests (blood cell analysis (five classification), blood biochemistry, coagulation function, urine routine and sediment), AFP...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Luoyang, Henan, China
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luoyang, Henan, China; Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.