このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II)

2019年7月2日 更新者：Janssen Sciences Ireland UC

A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Part 1: This is a first-in-human (FIH), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. Part 1 includes healthy adult participants, divided into 3 panels (Panel 1, 2 and 3) and in Part 2 adult Chronic Hepatitis B Participants will be included, in Sessions VIII to XI and Optional Sessions A-B-C (Panel 4). The study will consists of screening phase (part 1: [less than or equal to <=28 days before the first intake of study drug; part 2: [<=56 to greater than or equal to {>=} 20 days before the first intake of study drug), Treatment Phase (multiple dose phase in part 1: Day -1 up to 12 or 19 days; part 2: up to 4 weeks) and Follow up Phase (part 1: 30-35 days after last study drug intake or after dropout; part 2: up to week 8 after actual end of study drug treatment). Participants' safety will be evaluated throughout the study.

研究の種類

介入

入学 (実際)

87

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

  • グルジア
      • Tbilisi、グルジア
  • スペイン
      • Barcelona、スペイン
      • Madrid、スペイン
      • Santander、スペイン
      • Sevilla、スペイン
      • Valencia、スペイン
  • ドイツ
      • Essen、ドイツ
      • Hannover、ドイツ
      • Wiesbaden、ドイツ
  • フランス
      • Clichy、フランス
      • La Tronche、フランス
      • Lyon、フランス
      • Paris、フランス
  • ブルガリア
      • Sofia、ブルガリア
  • ベルギー
      • Brussel、ベルギー
      • Edegem、ベルギー
      • Mechelen、ベルギー
      • Merksem、ベルギー
  • マレーシア
      • Kuala Lumpur、マレーシア
  • モルドバ共和国
      • Chisinau、モルドバ共和国
  • ルーマニア
      • Bucuresti、ルーマニア
      • Timisoara、ルーマニア
  • 台湾
      • Kaohsiung、台湾
      • Keelung、台湾
      • Taichung、台湾
      • Taipei City、台湾
      • Taoyuan、台湾

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～65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • For Part II, a female participant must be either of a) Non-childbearing potential defined as: 1) Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (greater than (>)40 international unit per milliliter (IU/L) or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient, or 2) Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy, or b) Childbearing potential and practicing sexual abstinence or a highly effective method of contraception from screening onwards and agree to continue to use the same method of contraception throughout study treatment and for at least 90 days after the last dose of study drug (or longer, if dictated by local regulation)
  • Female participants should have a negative serum pregnancy test at screening
  • Healthy Participants: Participants must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m2), extremes included
  • Chronic Hepatitis B Participants: Participants must have lack of advanced liver disease, ie, either: Metavir F0-F2 (or comparable histologic scoring system) as determined on a liver biopsy within one year of the screening visit; a result based on specific radiologic liver disease staging modalities (eg, Fibroscan, AFRI, magnetic resonance imaging [MRI]-Elastography) compatible with Metavir F0-F2 within 6 months of the screening visit
  • Chronic Hepatitis B Participants: Participants must have HBV DNA of greater than or equal [>=] 2,000 international unit per milliliter (IU/mL) at screening
  • Chronic Hepatitis B Participants: Participants must be aged between 18 years to 65 years, have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 35.0 kilogram per square meter (kg/m^2), extremes included

Exclusion Criteria:

  • Healthy Participants: Participants with a past history of cardiac arrhythmias (example, extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Healthy Participants: Female participants who are breastfeeding at screening
  • Healthy Participants: Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
  • Chronic Hepatitis B Participants: Participants with current HCV infection (confirmed by HCV antibody or HCV RNA) or hepatitis delta virus (HDV) infection (confirmed by HDV antibody) at screening
  • Chronic Hepatitis B Participants: Participants with positivity of anti-HBs antibodies
  • Chronic Hepatitis B Participants: Participants with a past history of cardiac arrhythmias (eg, extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Chronic Hepatitis B Participants: Female participants who are breastfeeding 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：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Part 1: Single Dose Escalation
The single dose escalation phase of the study will consist of 6 dosing sessions (Sessions I to VI) evaluated in 2 panels (Panels 1 and 2). The dose of JNJ-56136379 will be consecutively escalated over 5 levels, alternating between the 2 panels. Panel 1 will receive 3 single doses (SD1, SD3 and SD3fed) in Sessions I, III and V, respectively. Panel 2 will receive 3 single doses (SD2, SD4 and SD5) in Sessions II, IV and VI, respectively. There will be a washout period of at least 14 days between consecutive JNJ-56136379/placebo dosing in each individual participant.
薬：JNJ-56136379
JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
薬：Placebo
Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
実験的：Part 1: Multiple dose session
After completion of the fifth single dose session another panel of healthy participant (panel 3) receive multiple doses of JNJ-56136379 at one dose level (MDx) or placebo for 12 or 19 consecutive days (Session VII) in fed or fasted conditions.
薬：JNJ-56136379
JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
薬：Placebo
Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
実験的：Part 2: Multiple dose escalation
Multiple dose levels will be given in Panel 4 in Session VIII (European sites), Sessions IX and X (European and/or Asian sites) Session XI (Asian sites) for 28 consecutive days in fed conditions. Optional Sessions A-B-C (Panel 4) used for further dose evaluations at European and/or Asian sites. Per session, participants will receive JNJ 56136379 or placebo. Dose progression to the next multiple dose level may be adapted based on the emerging safety and PK outcome of the previous dosing levels.
薬：JNJ-56136379
JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
薬：Placebo
Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).

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
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
時間枠：Until the last study-related activity (30-35 days after last dosing)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Until the last study-related activity (30-35 days after last dosing)
Part 2: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
時間枠：Up to Week 12
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to Week 12
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Abnormal Physical Examinations
時間枠：30-35 days after last study drug intake or after dropout
Physical examinations (including body weight measurement and skin examination) will be performed.
30-35 days after last study drug intake or after dropout
Part 2: Number of Participants With Abnormal Physical Examinations
時間枠：Up to Week 8
Physical examinations (including body weight measurement and skin examination) will be performed.
Up to Week 8
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Abnormal Vital Signs
時間枠：30-35 days after last study drug intake or after dropout
Vital signs (Supine Blood Pressure [SBP], Diastolic Blood Pressure [DBP] pulse rate: supine and standing) will be performed.
30-35 days after last study drug intake or after dropout
Part 2: Number of Participants With Abnormal Vital Signs
時間枠：Up to Week 8
Vital signs (SBP, DBP pulse rate: supine and standing) will be performed.
Up to Week 8
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Clinically Significant Laboratory Findings
時間枠：30-35 days after last study drug intake or after dropout
The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.
30-35 days after last study drug intake or after dropout
Part 2: Number of Participants With Clinically Significant Laboratory Findings
時間枠：Up to Week 8
The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.
Up to Week 8
Part 1: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration
時間枠：Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Cmax is the Maximum observed plasma concentration.
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Part 1: Maximum Observed Plasma Concentration (Cmax) After Multiple Dose Administration
時間枠：Pre-dose, 0.5 hr, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr Day 1; post-dose on Day 12
Cmax is the Maximum observed plasma concentration.
Pre-dose, 0.5 hr, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr Day 1; post-dose on Day 12
Part 2: Maximum Observed Plasma Concentration (Cmax)
時間枠：Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
Cmax is the Maximum observed plasma concentration.
Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
Part 1: Area Under the Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) After Single Dose Administration
時間枠：Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Part 2: Area Under the Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
時間枠：Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
Part 1: Area Under the Curve From Time 0 to Infinity (AUC infinity) After Single Dose Administration
時間枠：Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
AUC infinity is the area under the curve from time 0 to infinity.
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Part 2: Area Under the Curve From Time 0 to Infinity (AUC infinity)
時間枠：Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
AUC infinity is the area under the curve from time 0 to infinity.
Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28

二次結果の測定

結果測定
メジャーの説明
時間枠
Part 2: Change From Baseline in Mean Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
時間枠：Up to week 12
HBV DNA will be quantified using an in vitro nucleic acid amplification test for the quantification of HBV DNA.
Up to week 12
Part 2: Maximum Decrease in HBV DNA (Baseline-subtracted Mean)
時間枠：Up to week 12
HBV DNA will be quantified using an in vitro nucleic acid amplification test for the quantification of HBV DNA.
Up to week 12
Part 2: Changes in Hepatitis B Surface Antigen (HBsAg) Levels
時間枠：Up to week 12
Quantitative HBsAg and levels will be determined from samples using standard serologic assays.
Up to week 12
Part II: Percentage of Participants with Treatment Emerging Mutations
時間枠：Up to week 12
Treatment induced emerging mutations will be assessed by comparing the HBV genome sequence obtained at baseline with sequences obtained post-baseline.
Up to week 12
Part II: Change From Baseline in HBV DNA (Antiviral Activity) in Chronic Hepatitis B (CHB) Participants with Sequence Variations in the HBV Genome
時間枠：Up to week 12
Sequence variations in the HBV genome will be assessed by sequencing of the viral genome. Antiviral activity will be assessed by measuring change from baseline in HBV DNA concentration using in vitro nucleic acid amplification test for the quantification of HBV DNA and compared between participants with and without HBV sequence variations.
Up to week 12

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

Janssen Sciences Ireland UC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (実際)

2015年12月17日

一次修了 (実際)

2018年6月29日

研究の完了 (実際)

2018年6月29日

試験登録日

最初に提出

2015年12月2日

QC基準を満たした最初の提出物

2016年1月20日

最初の投稿 (見積もり)

2016年1月25日

学習記録の更新

投稿された最後の更新 (実際)

2019年7月5日

QC基準を満たした最後の更新が送信されました

2019年7月2日

最終確認日

2019年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CR108092
  • 56136379HPB1001 (その他の識別子：Janssen Sciences Ireland UC)
  • 2015-003724-30 (EudraCT番号)

医薬品およびデバイス情報、研究文書

米国FDA規制機器製品の研究

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。

JNJ-56136379の臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Gambia

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する