A Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Participants
2022年4月26日 更新者：Janssen Research & Development, LLC
A Randomized, Double-blind, Placebo- and Positive-controlled, Single-dose, 4 Way Crossover Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Subjects
The purpose of this study is to assess the effects of loperamide on QT/ QT interval corrected for heart rate (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy participants.
調査の概要
研究の種類
介入
入学 (実際)
66
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
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Merksem、ベルギー、2170
- Clinical Pharmacology Unit
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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
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- All female participants, except if postmenopausal, must have a negative serum beta-human chorionic gonadotropin (beta hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1 of each treatment period
- A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
- A male participant, who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Must have a body mass index (body mass index [BMI]; weight kilogram per meter per height per square per meter square [kg/height^2 m^2]) between 18.0 and 30.0 kg/m^2 (inclusive) with a body weight not lower than 50 kilogram (kg)
- Must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. Heart rate between 45 and 100 beats per minute (bpm), inclusive
Exclusion Criteria:
- History of or current renal insufficiency (estimated glomerular filtration rate [eGFR] less than (<) 90 milliliter per minute per meter square (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula at screening only)
- Clinically significant abnormal values for hematology, serum chemistry (including thyroid-stimulating hormone [TSH] at screening only) or urinalysis at screening or at admission to the study site, as deemed appropriate by the investigator. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
- Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at admission to the study site as deemed appropriate by the investigator
- Received a known inhibitor of Cytochrome (CY) P3A4, CYP3A4, CYP2C8, or P-glycoprotein (P-gp) activity within 14 days or a period less than 5 times the drugs' half-life; whichever is longer, before the first dose of the study drug is scheduled
- Received a known inducer of CYP3A4 or CYP2C8 activity within 28 days before the first dose of the study drug is scheduled
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：診断
- 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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Treatment Sequence 1: Treatment ADBC
Participants will receive treatment A (Loperamide therapeutic dose) on Day 1 on treatment period 1, followed by Treatment D (Moxifloxacin) on Day 1 of treatment period 2 followed by Treatment B (Loperamide supratherapeutic dose) on Day 1 of treatment period 3 followed by Treatment C (placebo) on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.
Matching loperamide placebo capsules will be administered orally.
Moxifloxacin tablets will be administered orally.
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実験的：Treatment Sequence 2: Treatment BACD
Participants will receive Treatment B on Day 1 of treatment period 1 followed by Treatment A on Day 1 of treatment period 2 then Treatment C on Day 1 of treatment period 3 and then Treatment D on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.
Matching loperamide placebo capsules will be administered orally.
Moxifloxacin tablets will be administered orally.
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実験的：Treatment Sequence 3: Treatment CBDA
Participants will receive Treatment C on Day 1 of treatment period 1 followed by Treatment B on Day 1 of treatment period 2 then Treatment D on Day 1 of treatment period 3 and then Treatment A on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.
Matching loperamide placebo capsules will be administered orally.
Moxifloxacin tablets will be administered orally.
|
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実験的：Treatment Sequence 1: Treatment DCAB
Participants will receive Treatment D on Day 1 of treatment period 1 followed by Treatment C on Day 1 of treatment period 2 then Treatment A on Day 1 of treatment period 3 and then Treatment B on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
|
Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.
Matching loperamide placebo capsules will be administered orally.
Moxifloxacin tablets will be administered orally.
|
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 |
|---|---|---|
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Change from Baseline in QT Interval Corrected for Heart Rate (QTc) Intervals for Loperamide
時間枠：Baseline up to 9 weeks
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Change from baseline in QTc intervals for loperamide at therapeutic and supratherapeutic doses will be reported.
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Baseline up to 9 weeks
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Percentage of Participants with Change from Baseline in T-wave Morphology
時間枠：Up to 9 weeks
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The percentage of participants in each treatment having T-wave morphology changes from baseline that represent the appearance or worsening of the morphological abnormality will be reported.
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Up to 9 weeks
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Percentage of Participants with Occurrence of Abnormal U-wave Morphology
時間枠：Up to 9 weeks
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The percentage of participants with the occurrence of abnormal U-waves morphology that represent the appearance or worsening of the morphological abnormality will be reported.
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Up to 9 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of Loperamide and its M1 Metabolite
時間枠：Up to 9 weeks
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Cmax is defined as the maximum observed plasma concentration.
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Up to 9 weeks
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Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Loperamide and its M1 Metabolite
時間枠：Up to 9 weeks
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Tmax is defined as the time to reach the maximum observed plasma concentration.
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Up to 9 weeks
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Area Under the Plasma Concentration-Time Curve from the Time of Dosing to the Last Measurable Plasma Concentration AUC (0-last) of Loperamide and its M1 Metabolite
時間枠：Up to 9 weeks
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AUC (0-last) is defined as the area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration.
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Up to 9 weeks
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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inifinity]) of Loperamide and M1 Metabolite
時間枠：Up to 9 weeks
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(AUC[0-inifinity]) is defined as the area under the plasma concentration-time curve from time zero to infinity, calculated as AUClast+Clast/lambda (z), where Clast is the last observed measurable concentration.
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Up to 9 weeks
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Apparent Terminal Elimination Rate Constant Lambda (z) of Loperamide and its M1 Metabolite
時間枠：Up to 9 weeks
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Lambda (z) is defined as the apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration versus time curve.
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Up to 9 weeks
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Apparent Elimination Half-Life Associated with the Terminal Slope (t1/2) of Loperamide and M1 Metabolite
時間枠：Up to 9 weeks
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t1/2 is defined as the apparent elimination half-life associated with the terminal slope lambda (z) of the semilogarithmic drug concentration-time curve.
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Up to 9 weeks
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Metabolite to parent ratio (M/P) for (AUC[0-inifinity]) of Loperamide and M1 Metabolite
時間枠：Up to 9 weeks
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M/p ratio is defined as metabolite to parent ratio (M/P) for (AUC[0-inifinity]) corrected for molecular weight using the following molecular weights: loperamide 477.045 gram per mol (g/mol), M1 463.018 g/mol.
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Up to 9 weeks
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Relationship Between Systemic Plasma Concentrations of Loperamide and QT/QTc Changes
時間枠：Up to 9 weeks
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The relationship between systemic plasma concentrations of loperamide and change in QT/QTc will be reported.
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Up to 9 weeks
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Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
時間枠：Up to 9 Weeks
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An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Up to 9 Weeks
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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。
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)
2020年1月17日
一次修了 (実際)
2021年12月21日
研究の完了 (実際)
2022年1月12日
試験登録日
最初に提出
2020年1月9日
QC基準を満たした最初の提出物
2020年1月9日
最初の投稿 (実際)
2020年1月13日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月27日
QC基準を満たした最後の更新が送信されました
2022年4月26日
最終確認日
2022年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CR108643
- 2019-003776-39 (EudraCT番号)
- R018553NAP1001 (その他の識別子：Janssen Research & Development, LLC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
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
はい
米国FDA規制機器製品の研究
いいえ
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