- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01986491
A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants
11. listopadu 2013 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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 studie
Intervenční
Zápis (Aktuální)
20
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Antwerp, Belgie
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 55 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
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Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
|
Experimentální: 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.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
|
Experimentální: 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.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
|
Experimentální: 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.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
|
Experimentální: 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.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
|
Experimentální: 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.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
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Experimentální: 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.
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Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Maximum plasma concentration of JNJ 39393406
Časové okno: 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)
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Maximum plasma concentration of JNJ 39393406, determined by visual inspection of the data
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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)
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Time to reach the maximum plasma concentration of JNJ 39393406
Časové okno: 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)
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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)
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Area under the plasma concentration-time curve of JNJ-39393406
Časové okno: 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
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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
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Number of participants with adverse events
Časové okno: Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)
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Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Ředitel studie: Johnson & Johnson Pharmaceutical Research & Development Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2009
Primární dokončení (Aktuální)
1. srpna 2009
Dokončení studie (Aktuální)
1. srpna 2009
Termíny zápisu do studia
První předloženo
11. listopadu 2013
První předloženo, které splnilo kritéria kontroly kvality
11. listopadu 2013
První zveřejněno (Odhad)
18. listopadu 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
18. listopadu 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. listopadu 2013
Naposledy ověřeno
1. listopadu 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CR016264
- 39393406EDI1003 (Jiný identifikátor: Johnson & Johnson Pharmaceutical Research & Development)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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