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A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function

This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.

It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B):

Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11.

During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.

Studietyp

Interventionell

Inskrivning (Faktisk)

24

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Changchun
      • Jilin City, Changchun, Kina, 130000
        • The First Hospital of Jilin University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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;

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: normal hepatic function group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Experimentell: mild hepatic impairment (Child-Pugh A) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Experimentell: moderate hepatic impairment (Child-Pugh B) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cmax
Tidsram: up to 12 weeks
maximum concentration
up to 12 weeks
AUC0-last
Tidsram: up to 12 weeks
area under the plasma concentration-time curve from 0 to the last quantifiable time point
up to 12 weeks
AUC0-inf
Tidsram: up to 12 weeks
area under the plasma concentration-time curve from 0 to infinity
up to 12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tmax
Tidsram: up to 12 weeks
time to reach maximum concentration
up to 12 weeks
CL/F
Tidsram: up to 12 weeks
apparent clearance
up to 12 weeks
Vz/F
Tidsram: up to 12 weeks
apparent volume of distribution
up to 12 weeks
t1/2
Tidsram: up to 12 weeks
terminal half-life
up to 12 weeks
body temperature
Tidsram: up to 12 weeks
Measure the body temperature of the subjects, using degrees Celsius as the unit.
up to 12 weeks
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
Tidsram: up to 12 weeks
The blood human chorionic gonadotropin (HCG) pregnancy test will measure the concentration of HCG in the blood of reproductive-aged women to determine if they are pregnant. The units in the report will be presented in IU/L (international units per liter) and/or mIU/mL.
up to 12 weeks
12-lead ECG
Tidsram: up to 12 weeks
Evaluate QT interval, PR interval, etc.
up to 12 weeks
adverse events and serious adverse events
Tidsram: up to 12 weeks
up to 12 weeks
Pulse
Tidsram: up to 12 weeks
Measure the pulse of the subjects, expressing it in units of beats per minute.
up to 12 weeks
Blood pressure
Tidsram: up to 12 weeks
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
up to 12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: YaNan Wang, PHD, The First Hospital of Jilin University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 september 2024

Primärt slutförande (Faktisk)

28 december 2024

Avslutad studie (Faktisk)

28 december 2024

Studieregistreringsdatum

Först inskickad

9 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • MY008211-1-09

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The company's business decision

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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