- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01431937
Assessment of Repeat Ascending Doses of GSK2018682 in Healthy Volunteers (P1A114347)
5 lipca 2017 zaktualizowane przez: GlaxoSmithKline
A Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Ascending Doses of GSK2018682 (S1P1 Agonist) in Healthy Volunteers
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat ascending doses of GSK2018682.
The study will also provide further evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute Lymphocyte Counts (ALC).
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat ascending doses of GSK2018682.
The study will also provide further evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute Lymphocyte Counts (ALC).
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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New South Wales
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Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- GSK Investigational Site
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- GSK Investigational Site
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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
18 lat do 55 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Females must be of non-childbearing potential.
- BMI within the range 19 - 29 kg/m2 (inclusive).
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Were participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Other exclusion criteria to be detailed at the time of physical screening by the Investigator
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: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: GSK2018682
Active Drug
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Active Drug
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Komparator placebo: Kontrola placebo
Placebo
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Placebo
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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To investigate the safety and tolerability of repeat oral doses of GSK2018682 in healthy volunteers (males and females of non-childbearing potential)
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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Adverse event monitoring, Laboratory parameters (haematology, clinical chemistry, urinalysis), Ophthalmic examination
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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To investigate effects of repeat oral doses of GSK2018682 on heart rate and blood pressure in healthy volunteers
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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12-lead ECG, Telemetry ECG, Holter ECG, Vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, body temperature), Ambulatory blood pressure monitoring
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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To investigate effects of repeat oral doses of GSK2018682 on lung function in healthy volunteers
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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FEV1 obtained via spirometry
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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To investigate the pharmacokinetics of repeat oral doses of GSK2018682 in healthy volunteers
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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Peak blood concentration, Time of peak blood concentration, Area under the blood concentration-time curve over the 24-hour dose interval and area under the blood concentration-time curve from time-zero extrapolated to infinite time, Accumulation ratio, Terminal half-life, Apparent oral clearance, Through concentration
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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To characterize the metabolism of GSK2018682
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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GSK2018682 bile metabolites, GSK2018682 whole blood metabolites
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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Evaluate the effect of repeat oral doses of GSK2018682 on lymphocytes in healthy volunteers
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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% Change from baseline in absolute lymphocyte counts (ALC), % Change from baseline in subsets CD3+ [CD4+ and CD8+], CD19+, CD16+/CD56+ counts, % Change from baseline in further defined functional T cell subsets (naïve, central memory, effector memory and regulatory T cells)
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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To explore the PK/PD relationship between blood concentrations and changes in vital signs and ECG parameters
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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PK/PD model with parameters of the models will be determined that best describe the relationship between blood concentrations of GSK2018682 and vital signs and ECG parameters
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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To explore the PK/PD relationship between blood concentrations of GSK2018682 and reduction in lymphocyte counts
Ramy czasowe: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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PK/PD model with parameters of the models will be determined that best describe the relationship between blood concentrations of GSK2018682 and reduction ALC and subset counts CD3+ [CD4+ and CD8+], CD19+, CD16+/CD56+ and further defined functional T cell subsets (naïve, central memory, effector memory and regulatory T cells)
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Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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)
10 października 2010
Zakończenie podstawowe (Rzeczywisty)
29 marca 2011
Ukończenie studiów (Rzeczywisty)
29 marca 2011
Daty rejestracji na studia
Pierwszy przesłany
11 sierpnia 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 września 2011
Pierwszy wysłany (Oszacować)
12 września 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
7 lipca 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 lipca 2017
Ostatnia weryfikacja
1 lipca 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 114347
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Badanie danych/dokumentów
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Indywidualny zestaw danych uczestnika
Identyfikator informacji: 114347Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Formularz zgłoszenia przypadku z adnotacjami
Identyfikator informacji: 114347Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Formularz świadomej zgody
Identyfikator informacji: 114347Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Protokół badania
Identyfikator informacji: 114347Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Plan analizy statystycznej
Identyfikator informacji: 114347Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Raport z badania klinicznego
Identyfikator informacji: 114347Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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Specyfikacja zestawu danych
Identyfikator informacji: 114347Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
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 .