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Official title To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage
ClinicalTrials.gov ID: NCT06376474
What this study is testing
What is Hemay005?
Hemay005 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for psoriasis.
Also referred to as Hemay005 tablet.
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
- The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
- 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 70. Healthy volunteers may be eligible.
You may be able to join if
- 1\. Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign...
- 2\. Adults of both sexes aged from 18 to 70 years old (both ends, based on written informed consent);
- 3\. The body weight of male people should not be less than 50 kg and the body weight of female people should not be less than 45 kg. Body mass index...
- 4\. chronic stable liver impairment (no clinically significant change in disease status as judged by the investigator to have occurred for at least...
- 5\. (Inquiry) patients who have a stable medication plan for the treatment of liver function impairment, complications, and other concomitant...
You likely can't join if
- 1\. (Inquiry) The subject has any of the following conditions: previous liver transplantation; Severe portal hypertension or transsurgical...
- 2\. (Inquiry) In addition to the disease causing liver function impairment, patients with serious acute or chronic diseases of other important organs...
- 3\. (Inquiry) Any of the following occurred within 6 months prior to study entry: Myocardial infarction, Congenital long QT syndrome, Torsades de...
- 4\. (asking) a history of depression or suicidal tendencies;
- 5\. (Inquiry) patients who had severe gastrointestinal diseases (except secondary gastrointestinal diseases caused by hepatitis) or had digestive...
- 6\. (Inquiry) patients who lost blood or donated more than 400mL of blood within one month before screening, or received red blood cell transfusion;
See the full eligibility criteria
Who can join
- 1\. Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign the informed consent according to the requirements of the trial protocol;
- 2\. Adults of both sexes aged from 18 to 70 years old (both ends, based on written informed consent);
- 3\. The body weight of male people should not be less than 50 kg and the body weight of female people should not be less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);
- 4\. chronic stable liver impairment (no clinically significant change in disease status as judged by the investigator to have occurred for at least 28 days (or up to 14 days for patients with moderate liver function)...
- 5\. (Inquiry) patients who have a stable medication plan for the treatment of liver function impairment, complications, and other concomitant diseases for at least 28 days (or 14 days for patients with moderate liver...
- 6.In addition to liver function damage and complications, the investigators were in good physical condition according to medical history inquiry, vital signs, physical examination, laboratory tests (blood routine, urine...
What rules you out
- 1\. (Inquiry) The subject has any of the following conditions: previous liver transplantation; Severe portal hypertension or transsurgical portosystemic shunt; Patients with suspected or confirmed liver cancer or other...
- 2\. (Inquiry) In addition to the disease causing liver function impairment, patients with serious acute or chronic diseases of other important organs within 1 year before screening, including but not limited to...
- 3\. (Inquiry) Any of the following occurred within 6 months prior to study entry: Myocardial infarction, Congenital long QT syndrome, Torsades de pointes (including sustained ventricular tachycardia and ventricular...
- 4\. (asking) a history of depression or suicidal tendencies;
- 5\. (Inquiry) patients who had severe gastrointestinal diseases (except secondary gastrointestinal diseases caused by hepatitis) or had digestive system surgery within 3 months before screening, and the investigators...
- 6\. (Inquiry) patients who lost blood or donated more than 400mL of blood within one month before screening, or received red blood cell transfusion;
- 7\. (Inquiry) Liver function fluctuation (e.g., active hepatitis), rapid deterioration (e.g., advanced ascites, fever, active gastrointestinal bleeding), CTCAE 5.0 common adverse event grade ≥ 2, ongoing arrhythmia...
- 8.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) \>5 times the normal value; (b) neutrophil count \ 50 ng/mL and suspected hepatocellular carcinoma;
- 9\. (Inquiry) patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic condition (such as allergic to two or more drugs, foods or pollens), or known allergic to PDE4 inhibitors (such as...
- 10\. (inquiry) those who had a history of drug abuse in the past 5 years or drug abuse in the past 3 years before screening;
- 11\. Screen-positive for drug abuse (except those screen-positive for drug abuse due to concomitant medication);
- 12\. Positive breath alcohol test (alcohol concentration \>0mg/L);
- 13\. (Inquiry) who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44 mL of 40% liquor or 147 mL of 12% wine), or who could...
- 14\. (Inquiry) who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study;
- 15\. (Inquiry) people who consumed excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup =250 mL) per day in the previous 3 months;
- 16\. Having one or more of the tests for hepatitis B, C, HIV and syphilis clinically significant;
- 17\. (Inquiry) who participated in clinical trials of other drugs/devices within 3 months before screening and used the trial drugs/devices;
- 18\. (Inquiry) who had received drugs with definite potential hepatotoxicity (such as acetaminophen, statins, azithromycin, dapsone, clarithromycin, fluconazole, ketoconazole, rifampicin, etc.) for 7 consecutive days or...
- 19\. (Inquiry) Use of any drugs (e.g., inductors-barbiturates, pioglitazone, carbamazepine, phenytoin, glucocorticoids) that induce or inhibit hepatic drug-metabolizing enzymes within 30 days before screening...
- 20\. (Inquiry) who used prescription drugs, over-the-counter drugs, health supplements, herbal products or vaccines other than those used for liver function impairment and other concomitant diseases within 2 weeks...
- 21\. (Inquiry) any caffeine/xanthine/food or drink (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in caffeine/xanthine/may affect the absorption, distribution...
- 22\. (Asking) pregnant or lactating women, or people (including male people) who have plans to give birth or donate sperm or eggs from two weeks before the trial to six months after the last dose of drug, unwilling or...
- 23\. (inquiry) those who are unable to eat or have swallowing difficulties, have special dietary requirements and/or cannot follow a uniform diet;
- 24\. (inquiry) with a history of epileptic seizures;
- 25\. (Inquiry) Those who cannot tolerate venipuncture and/or have a history of dizzy with blood and needles;
- 26\. people with other factors considered by the investigator to be ineligible for the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.