- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02821858
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
28 marca 2018 zaktualizowane przez: Janssen Research & Development, LLC
A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects
The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
40
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Surrey, Zjednoczone Królestwo
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
20 lat do 55 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must have a body mass index (BMI: weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included and a body weight not less than 50.0 kilogram (kg)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Participant must have a blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
- Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days (Panel 1) or 30 days (Panel 2) after study drug administration or until the last follow-up visit, whichever occurs later
Exclusion Criteria:
- Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic or metabolic disturbances
- Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant with a past history of heart arrhythmias (for example, extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first-degree relative [for example, sibling, offspring, or biological parent])
- Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV) or AL-335 or its excipients
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Panel 1: Treatment A
Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
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Zostanie podane pasujące placebo.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Eksperymentalny: Panel 1: Treatment B
Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
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Zostanie podane pasujące placebo.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Eksperymentalny: Panel 1: Treatment C
Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
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Zostanie podane pasujące placebo.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Eksperymentalny: Panel 2: Treatment D
Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1.
Each treatment period will be separated by a washout period of 7 days.
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Zostanie podane pasujące placebo.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Eksperymentalny: Panel 2: Treatment E
Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days.
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Zostanie podane pasujące placebo.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Eksperymentalny: Panel 2: Treatment F
Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3.
Each treatment period will be separated by a washout period of 7 days.
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Zostanie podane pasujące placebo.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
Ramy czasowe: From Day 1 to Day 14 after intake of ODV
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The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
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Time to Reach Maximum Observed Concentration (Tmax) of ODV
Ramy czasowe: From Day 1 to Day 14 after intake of ODV
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
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Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
Ramy czasowe: From Day 1 to Day 50-55 after intake of ODV
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The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
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From Day 1 to Day 50-55 after intake of ODV
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Elimination Rate Constant (Lambda[z]) of ODV
Ramy czasowe: From Day 1 to Day 50-55 after intake of ODV
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Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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From Day 1 to Day 50-55 after intake of ODV
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Elimination Half-Life (t1/2) of ODV
Ramy czasowe: From Day 1 to Day 50-55 after intake of ODV
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Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 50-55 after intake of ODV
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Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
Ramy czasowe: From Day 1 to Day 50-55 after intake of ODV
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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From Day 1 to Day 50-55 after intake of ODV
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
Ramy czasowe: Up to 50-55 days after intake of ODV
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Up to 50-55 days after intake of ODV
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Maximum Observed Concentration (Cmax) of AL-335
Ramy czasowe: From Day 1 to Day 4 after intake of AL-335
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The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 4 after intake of AL-335
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Time to Reach Maximum Observed Concentration (Tmax) of AL-335
Ramy czasowe: From Day 1 to Day 4 after intake of AL-335
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The Tmax is defined as actual sampling time to reach maximum observed concentration.
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From Day 1 to Day 4 after intake of AL-335
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Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
Ramy czasowe: From Day 1 to Day 4 after intake of AL-335
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The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
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From Day 1 to Day 4 after intake of AL-335
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Elimination Rate Constant (Lambda[z]) of AL-335
Ramy czasowe: From Day 1 to Day 4 after intake of AL-335
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Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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From Day 1 to Day 4 after intake of AL-335
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Elimination Half-Life (t1/2) of AL-335
Ramy czasowe: From Day 1 to Day 4 after intake of AL-335
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Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 4 after intake of AL-335
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Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
Ramy czasowe: From Day 1 to Day 4 after intake of AL-335
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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From Day 1 to Day 4 after intake of AL-335
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
Ramy czasowe: Up to 30 to 35 days after last intake of AL-335
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Up to 30 to 35 days after last intake of AL-335
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Dyrektor Studium: Janssen Research and Developement, LLC Clinical Trial, Janssen Research and Developement, LLC
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
14 czerwca 2016
Zakończenie podstawowe (Rzeczywisty)
9 września 2016
Ukończenie studiów (Rzeczywisty)
30 września 2016
Daty rejestracji na studia
Pierwszy przesłany
10 czerwca 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 czerwca 2016
Pierwszy wysłany (Oszacować)
4 lipca 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
29 marca 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 marca 2018
Ostatnia weryfikacja
1 marca 2018
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CR108178
- 64294178HPC1005 (Inny identyfikator: Janssen Research & Development, LLC)
- 2015-005639-42 (Numer EudraCT)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
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 .