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

11 novembre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Sperimentale: 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.
Droga: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Sperimentale: 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.
Droga: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Sperimentale: 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.
Droga: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Sperimentale: 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.
Droga: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 30 mg solution
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
Sperimentale: 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.
Droga: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Droga: JNJ 39393406 30 mg solution
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
Sperimentale: 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.
Droga: JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Droga: JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum plasma concentration of JNJ 39393406
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Investigatori

  • Direttore dello studio: Johnson & Johnson Pharmaceutical Research & Development Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2009

Completamento primario (Effettivo)

1 agosto 2009

Completamento dello studio (Effettivo)

1 agosto 2009

Date di iscrizione allo studio

Primo inviato

11 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

11 novembre 2013

Primo Inserito (Stima)

18 novembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 novembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 novembre 2013

Ultimo verificato

1 novembre 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • CR016264
  • 39393406EDI1003 (Altro identificatore: Johnson & Johnson Pharmaceutical Research & Development)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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