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A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants

11 listopada 2013 zaktualizowane przez: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-Label, Single Dose, Relative Bioavailability Study of Solid Formulations in Fed and Fasted Conditions Followed by a Repeated Dose Study of a Selected Solid Formulation of JNJ-39393406 in Healthy Male Subjects

The purpose of the study is to compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be selected to investigate the pharmacokinetics in fasting condition in Part 2 and after repeated dosing in Part 3.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is an open-label (all people know the identity of the intervention) and single center study that will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3 phases including, the screening phase, treatment phase, and the follow-up phase. Part 1 is a four-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) study to compare the pharmacokinetics, dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations (X and Y). Approximately 12 participants will be enrolled in Part 1. Part 2 is two-way cross-over study in a separate group of participants to assess pharmacokinetics in fasting condition and the relative bioavailability (the extent to which a medication or other substance becomes available to the body) of the selected solid formulation from Part 1 compared with a solution formulation. Approximately 8 participants will be enrolled in Part 2. In Part 3, the single and repeated dose pharmacokinetics after administration of the selected formulation from Part 1 will be assessed for 7 consecutive days. The same participants will participate in Parts 2 and 3 of the study. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, and neurological examination. The duration of participation in the study for an individual participant will be approximately 8 weeks (including screening and follow up visit).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

20

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Nie

Płeć kwalifikująca się do nauki

Męski

Opis

Inclusion Criteria:

  • Healthy male participants
  • Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
  • Willing to adhere to the prohibitions and restrictions specified in the protocol
  • Must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  • Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission
  • Clinically significant abnormal physical examination, neurological examination, vital signs or 12 lead electrocardiogram at screening
  • Significant history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant
  • Significant history of or current psychiatric or neurological illness
  • Serology positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies at screening

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: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Part 1; Period 1
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid X, 120 mg of solid Y, 30 mg of solid Y, and 120 mg of solid X.
Lek: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Eksperymentalny: Part 1; Period 2
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid Y, 30 mg of solid X, 120 mg of solid X and 120 mg of solid Y.
Lek: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Eksperymentalny: Part 1; Period 3
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid X, 30 mg of solid Y, 120 mg of solid Y, and 30 mg of solid X.
Lek: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Eksperymentalny: Part 1; Period 4
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid Y, 120 mg of solid X, 30 mg of solid X, and 30 mg of solid Y.
Lek: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Eksperymentalny: Part 2; Period 1
Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solid formulation, and 30 mg of solution.
Lek: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 30 mg solution
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
Eksperymentalny: Part 2; Period 2
Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solution, and 30 mg of solid formulation.
Lek: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Lek: JNJ 39393406 30 mg solution
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
Eksperymentalny: Part 3
Eight participants (same participants from Part 2) will receive JNJ 39393406 (dose will likely be 30 mg, or another multiple of the 30 mg solid dose form selected in Part 1, but not higher than 210 mg) from Days 1 to 7.
Lek: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Lek: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Maximum plasma concentration of JNJ 39393406
Ramy czasowe: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Maximum plasma concentration of JNJ 39393406, determined by visual inspection of the data
Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Time to reach the maximum plasma concentration of JNJ 39393406
Ramy czasowe: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Time to reach the maximum plasma concentration, determined by visual inspection of the data
Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Area under the plasma concentration-time curve of JNJ-39393406
Ramy czasowe: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3
Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3
Number of participants with adverse events
Ramy czasowe: Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)
Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Śledczy

  • Dyrektor Studium: Johnson & Johnson Pharmaceutical Research & Development Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

1 maja 2009

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2009

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2009

Daty rejestracji na studia

Pierwszy przesłany

11 listopada 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 listopada 2013

Pierwszy wysłany (Oszacować)

18 listopada 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

18 listopada 2013

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 listopada 2013

Ostatnia weryfikacja

1 listopada 2013

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • CR016264
  • 39393406EDI1003 (Inny identyfikator: Johnson & Johnson Pharmaceutical Research & Development)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

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 .

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