A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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-
Changchun
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Jilin City, Changchun, Chiny, 130000
- The First Hospital of Jilin University
-
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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;
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: moderate hepatic impairment (Child-Pugh B) group
|
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Cmax
Ramy czasowe: up to 12 weeks
|
maximum concentration
|
up to 12 weeks
|
|
AUC0-last
Ramy czasowe: 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
Ramy czasowe: up to 12 weeks
|
area under the plasma concentration-time curve from 0 to infinity
|
up to 12 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Tmax
Ramy czasowe: up to 12 weeks
|
time to reach maximum concentration
|
up to 12 weeks
|
|
CL/F
Ramy czasowe: up to 12 weeks
|
apparent clearance
|
up to 12 weeks
|
|
Vz/F
Ramy czasowe: up to 12 weeks
|
apparent volume of distribution
|
up to 12 weeks
|
|
t1/2
Ramy czasowe: up to 12 weeks
|
terminal half-life
|
up to 12 weeks
|
|
body temperature
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: up to 12 weeks
|
Evaluate QT interval, PR interval, etc.
|
up to 12 weeks
|
|
adverse events and serious adverse events
Ramy czasowe: up to 12 weeks
|
up to 12 weeks
|
|
|
Pulse
Ramy czasowe: up to 12 weeks
|
Measure the pulse of the subjects, expressing it in units of beats per minute.
|
up to 12 weeks
|
|
Blood pressure
Ramy czasowe: up to 12 weeks
|
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
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up to 12 weeks
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Współpracownicy i badacze
Śledczy
- Główny śledczy: YaNan Wang, PHD, The First Hospital of Jilin University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MY008211-1-09
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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