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

2013年11月11日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (実際)

20

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～55年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

男

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
実験的：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.
薬：JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
実験的：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.
薬：JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
実験的：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.
薬：JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
実験的：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.
薬：JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 30 mg solution
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
実験的：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.
薬：JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 120 mg solid X
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 120 mg solid Y
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
薬：JNJ 39393406 30 mg solution
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
実験的：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.
薬：JNJ 39393406 30 mg solid X
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
薬：JNJ 39393406 30 mg solid Y
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Maximum plasma concentration of JNJ 39393406
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

捜査官

  • スタディディレクター：Johnson & Johnson Pharmaceutical Research & Development Clinical Trial、Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年5月1日

一次修了 (実際)

2009年8月1日

研究の完了 (実際)

2009年8月1日

試験登録日

最初に提出

2013年11月11日

QC基準を満たした最初の提出物

2013年11月11日

最初の投稿 (見積もり)

2013年11月18日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年11月18日

QC基準を満たした最後の更新が送信されました

2013年11月11日

最終確認日

2013年11月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • CR016264
  • 39393406EDI1003 (その他の識別子：Johnson & Johnson Pharmaceutical Research & Development)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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