Liver function and drug processing: a safety study
NCT ID NCT07625618
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a single dose of MY008211A tablets moves through the body in people with different levels of liver function. 24 adults (some with liver problems, some without) took part. The goal was to understand safety and how the liver affects drug levels, not to treat any condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements; * Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female; * Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive); * Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs; * Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min; Exclusion Criteria: * Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency; * Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila. * Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection; * Active systemic bacterial, viral or fungal infections within 14 days before administration; * Fever (≥ 38°C) within 7 days before administration; * Subjects suspected of having a history of allergy to any component of the investigational product, or with allergic constitution (allergic to multiple drugs and foods, and judged by the investigator to be clinically significant); * Those who have previously undergone surgery that, as judged by the investigator, will affect drug absorption, distribution, metabolism and excretion; or those who have undergone surgery within 4 weeks prior to screening; or those who plan to undergo surgery during the study; * Those who cannot tolerate venipuncture or with a history of blood phobia and acupuncture syncope;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Hospital of Jilin University
Jilin City, Changchun, 130000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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