- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02731885
Food Effect on Pharmacokinetic Parameters of ABX464
An Open, Randomized Study, to Investigate the Potential Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This is a phase I, single-center, open-label, two-treatment, food-effect, randomized study in 40 healthy Caucasian male subjects in order to determine the impact of the food on the absorption of the ABX464.
The two different treatments are the followings:
- Treatment A = 50mg of ABX464 (two 25mg capsules) /Fasted
- Treatment B = 50mg of ABX464 (two 25mg capsules) / Fed
This study consists of two groups:
- Group 1 - single dose assessments, two-period, two-treatment, cross-over: 20 subjects will receive a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
- Group 2 - multiple dose assessments: 20 subjects will receive 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Phoenix
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Sayed Hossen road, Phoenix, Mauritius
- CAP Research
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Healthy Caucasian male subjects, 18-55 years of age
- Body Mass Index (BMI) of 17-28 kg/m².
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
Normal vital signs after 10 minutes resting in supine position:
90 mmHg < systolic blood pressure < 140 mmHg, 50 mmHg < diastolic blood pressure < 90 mmHg, 40 bpm < heart rate < 100 bpm.
- Normal automatic 12-lead ECG (incomplete right bundle branch block can be accepted) or judged as non clinically significant.
- Clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to Investigator and Sponsor.
- Subjects must be willing to give written informed consent prior to study enrollment and be able to adhere to restrictions and examination schedules.
Exclusion Criteria:
- Individuals with a history of any significant medical disorder which requires a physician's care (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease; any acute infectious disease or signs of acute illness)
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month).
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician.
- Individuals who have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to drug administration.
- Any individual who does not comply with the requirement that he should not have used any drugs other than paracetamol for at least 2 weeks prior to the study nor alcohol within 48 hours prior to drug administration.
- Individuals who are positive for hepatitis B virus, hepatitis C virus or HIV.
- History or presence of drug or alcohol abuse (positive urine drug screen, positive alcohol breath test).
- Smoking more than 5 cigarettes or equivalent / day, unable to stop smoking during the study.
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day).
- Subject who will likely be unable to eat entirely the standard high fat breakfast within the allocated time.
- Individuals who have donated blood within the preceding 3 months.
- Individuals who refuse to use an effective method of contraception from the beginning of the study and until 3 months after dosing.
- Individuals with forfeiture of freedom by an administrative or legal obligation or under guardianship
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Fasted Conditions
50mg of ABX464 (two 25mg capsules) /Fasted
|
Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
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Eksperymentalny: Fed Conditions
50mg of ABX464 (two 25mg capsules) /Fed
|
Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Ramy czasowe: 45 days
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45 days
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Peak Plasma Concentration (Cmax) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Ramy czasowe: 45 days
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45 days
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Area under the plasma concentration versus time curve (AUC) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Ramy czasowe: 10 days
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10 days
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Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Ramy czasowe: 10 days
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10 days
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Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0
Ramy czasowe: Up to 45 days
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Up to 45 days
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- ABX464-FE-001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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