- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04859439
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment
An Open-label, Single-dose, Phase I Clinical Study to Assess the Pharmacokinetics and Safety of DBPR108 Tablets in Subjects With Varying Degrees of Renal Impairment Compared to the Control Subjects With Normal Renal Function
Przegląd badań
Szczegółowy opis
This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, safety, and tolerability of a single dose of DBPR108 100 mg in subjects with mild, moderate, and severe renal impairment (RI), subjects with kidney failure and the control subjects with normal renal function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 3), and a follow-up call on Day 6.
Subjects will be enrolled in the following groups:
Estimated glomerular filtration rate (eGFR) will be calculated based on Modification of Diet in Renal Disease (MDRD) equation at screening.
(A) mild renal impairment (60 ≤ eGFR≤ 89 mL/min/1.73m2); (B) moderate renal impairment (30 ≤ eGFR≤ 59 mL/min/1.73m2); (C) severe renal impairment (15 ≤ eGFR≤ 29 mL/min/1.73m2); (D) kidney failure (<15 mL/min/1.73m2, not on hemodialysis); (E) control subjects with normal renal function will be matched with subjects with HI by weight, age, and sex (eGFR≥90 mL/min/1.73m2).
Approximately 8 subjects will be enrolled in each group.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Suzhou, Chiny
- First Affiliated Hospital of Soochow University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
All subjects:
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 years to 79 years (inclusive), male and female;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m2));
- Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration;
Subjects with RI only:
- Subjects with medically stable RI corresponding to the Classifications of Renal Function based on eGFR: mild RI: 60 to 89 ml/min/1.73m2; moderate RI: 30 to 59 ml/min/1.73m2, severe RI:15-29 ml/min/1.73m2, kidney failure:<15 ml/min/1.73m2 (not on hemodialysis);
- Not in use of any prescription drug, over-the-counter drug, or herbal medicine within 2 weeks prior to screening, except for the medication necessary for RI/ other comorbidities with no effect on the study drug absorption, distribution, metabolism, or excretion (last more than four weeks in good compliance);
- Based on physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests (serum potassium: 3.5-5.5 mmol/L);
Subjects with normal renal function only:
- Weight, age, and sex must be matched with subjects with HI;
- eGFR≥90 ml/min/1.73m2;
- Not in use of any prescription drug, over-the-counter drug, or herbal medicine within 2 weeks prior to screening, except for the medication necessary for underlying conditions other than renal disease with no effect on the study drug absorption, distribution, metabolism, or excretion (last more than four weeks in good compliance).
Exclusion Criteria:
All subjects:
- Subjects who have a history of allergic conditions (such as asthma, urticaria), or have a history of allergy to two or more drugs or food, or may be allergic to the test drug and the related compounds;
- Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening;
- Have previously undergone surgery that may affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;
- Use of any DPP-IV enzyme inhibitor within 2 weeks prior to the screening;
- Drug abuse, or positive urine drug screen at screening;
- Smoking more than 5 cigarettes per day within 3 months prior to screening;
- Average alcohol intake is more than 28g alcohol (male) or 14g (female) per week (14g ≈ 497mL beer, or 44mL spirits with low alcohol content, or 145mL wine) within the 3 months prior to screening, or taking any alcohol within 48 hours before dosing, or a positive ethanol breath test at screening;
- Consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 48 hours before the administration, or have strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- Participation in another clinical trial within 3 months before screening;
- Blood donation (or blood loss) ≥400 mL, or receiving whole blood transfusions or erythrocyte suspension transfusions within 3 months prior to the screening;
- Have acute hepatitis or a chronic liver disease; aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin > 2 × upper limit of normal;
- Have a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or anti-treponema pallidum specific antibody;
- A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
- Currently receiving, or unable to refrain from expected concomitant cytochrome (CYP) 3A inhibitors and inducers;
- Not suitable for this study as judged by the investigator.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Mild Renal Impairment
Subjects will receive a single dose of 100 mg DBPR108
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Lek: DBPR108, tabletka, doustnie
Inne nazwy:
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Eksperymentalny: Moderate Renal Impairment
Subjects will receive a single dose of 100 mg DBPR108
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Lek: DBPR108, tabletka, doustnie
Inne nazwy:
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Eksperymentalny: Severe Renal function
Subjects will receive a single dose of 100 mg DBPR108
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Lek: DBPR108, tabletka, doustnie
Inne nazwy:
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Eksperymentalny: Kidney failure
Subjects will receive a single dose of 100 mg DBPR108
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Lek: DBPR108, tabletka, doustnie
Inne nazwy:
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Eksperymentalny: Normal Renal function
Subjects will receive a single dose of 100 mg DBPR108
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Lek: DBPR108, tabletka, doustnie
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
The pharmacokinetic parameters of DBPR108 in plasma
Ramy czasowe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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Cmax
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Ramy czasowe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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AUC0-t
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Ramy czasowe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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AUC0-inf
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Ramy czasowe: predose and 48 hours after dosing
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Ae
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predose and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Ramy czasowe: predose and 48 hours after dosing
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fe
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predose and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Ramy czasowe: predose and 48 hours after dosing
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CLR
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predose and 48 hours after dosing
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
The pharmacokinetic parameters of DBPR108 in plasma
Ramy czasowe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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Tmax
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Ramy czasowe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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t1/2
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Ramy czasowe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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Vz/F
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Ramy czasowe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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CL/F
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Ramy czasowe: predose and 48 hours after dosing
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Ae(t1-t2)
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predose and 48 hours after dosing
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The number of volunteers with adverse events as a measure of safety and tolerability
Ramy czasowe: Day 1 to Day 6
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The number of volunteers with adverse events as a measure of safety and tolerability
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Day 1 to Day 6
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Współpracownicy i badacze
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
- HA1118-CSP-009
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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