RecruitingPhase 1

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage

China24 participantsStarted 2024-04-28

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.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 routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, electroencephalogram, etc.), and no other clinically significant abnormalities.

Exclusion criteria

.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) \>5 times the normal value; (b) neutrophil count \<1.0×109/L; (c) hemoglobin (HGB) \<90 g/L; (d) platelet level \<50×109/L; (e) subjects with alpha-fetoprotein (AFP) \>50 ng/mL and suspected hepatocellular carcinoma;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，half-life (T1/2)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，clearance (CL/F)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，volume of distribution (Vz/F)

Timeframe: Day1-Day6

Trial details

NCT IDNCT06376474

SponsorGanzhou Hemay Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-10

Contact for this trial

Zimeng Wang

022-24929667 wangzimeng@hemay.com.cn

View on ClinicalTrials.gov More Psoriasis trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.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 routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, electroencephalogram, etc.), and no other clinically significant abnormalities.

Exclusion criteria

.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) \>5 times the normal value; (b) neutrophil count \<1.0×109/L; (c) hemoglobin (HGB) \<90 g/L; (d) platelet level \<50×109/L; (e) subjects with alpha-fetoprotein (AFP) \>50 ng/mL and suspected hepatocellular carcinoma;

What they're measuring

Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，half-life (T1/2)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，clearance (CL/F)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，volume of distribution (Vz/F)

Timeframe: Day1-Day6