A Study to Evaluate the Effects of Therapeutic and Supratherapeutic Doses of KRP-S124 Compared to Placebo With Moxifloxacin on QTc Interval in Healthy Participants
A Randomized, Partially Double-Blind, Five-Period, Five-Treatment, Crossover Study to Assess the Effects of KRP-S124 on QTc Interval Using Therapeutic and Supratherapeutic Doses Compared to Placebo, With Moxifloxacin as a Positive Control, in Healthy Participants: A Thorough QTc Study
This study is being done to see how KRP-S124 affects the electrical activity of the heart (known as the QTc interval [QT interval corrected for heart rate]) in healthy volunteers. This helps researchers check the heart safety of the study drug.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Clinical Development Center Kyorin Pharmaceutical Co., Ltd.
- 電話番号:+81-3-6368-4834
- メール:ml-kyorin_clinicaltrials.gov@mb.kyorin-pharm.co.jp
研究場所
-
-
Quebec
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Québec、Quebec、カナダ
- 募集
- Syneos Health
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or non-childbearing potential female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than or equal to (>=) 18 and less than or equal to (<=) 55 years of age, with body mass index (BMI) greater than (>) 18.5 and less than (<) 30.0 kilograms per square meter (kg/m^2) and body weight >=50.0 kilograms (kg) for males and >=45.0 kg for females.
- Female participants of non-childbearing potential should not donate ova for 90 days after the last dose.
- Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose.
- Male participants must be willing not to donate sperm for 90 days after the last dose.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
Exclusion Criteria:
- Any clinically significant abnormal finding at physical examination at screening or Baseline (Day -1 of Period 1).
- Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
- Any of the following laboratory parameters above the upper limit of normal (ULN) values at Screening or Baseline (Day -1 of Period 1): alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl-transpeptidase (GGT), direct bilirubin and total bilirubin. Only abnormal values between 1-1.5 * ULN may be repeated once for confirmation to below ULN.
- Known allergic reactions to KRP-S124 or other related drugs, or to any excipient in the formulation.
- Clinically significant vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimeters of mercury [mmHg], diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 beats per minute [bpm]) at screening or Baseline (Day -1 of Period 1).
- History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5 percent (%), 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing (or 5 half-lives, whichever is longer), administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing (or 5 half-lives, whichever is longer), or concomitant participation in an investigational study involving no drug or device administration.
- History of sustained and non-sustained cardiac arrhythmias (ECG demonstrated), family history of sudden cardiac death, and history of additional risk factors for Torsade-de-pointes, (e.g. [for example]: heart failure, hypokalemia, unexplained syncope, family history of Long QT Syndrome).
- Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
研究計画
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Treatment T (Therapeutic Dose)
Participants will receive a single oral dose of Therapeutic dose (T) (KRP-S124 [low dose]) and placebo matched to KRP-S124. |
Orally. Orally. |
|
実験的:Treatment ST1 (Supratherapeutic Dose 1)
Participants will receive a single oral dose of Supratherapeutic dose 1 (ST1) (KRP-S124 [medium dose]) and placebo matched to KRP-S124. |
Orally. Orally. |
|
実験的:Treatment ST2 (Supratherapeutic Dose 2)
Participants will receive a single oral dose of Supratherapeutic dose 2 (ST2) (KRP-S124 [high dose]). |
Orally. |
|
プラセボコンパレーター:Treatment P (Placebo)
Participants will receive a single oral dose of placebo matched to KRP-S124. |
Orally. |
|
アクティブコンパレータ:Treatment M (Moxifloxacin)
Participants will receive a single oral dose of moxifloxacin (M). |
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 |
|---|---|---|
|
Placebo-corrected Change From Baseline in Fridericia's Corrected QT interval (delta delta [ΔΔ]QTcF) for KRP-S124
時間枠:Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
Placebo-corrected change from baseline QTcF will be reported using a linear mixed-effects model analysis. |
Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Placebo-corrected Change From Baseline in Heart Rate (ΔΔHR) for KRP-S124
時間枠:Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
Placebo-corrected change from baseline HR will be reported using a linear mixed-effects model analysis. |
Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
|
Placebo-corrected Change From Baseline in PR interval (ΔΔPR) for KRP-S124
時間枠:Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
Placebo-corrected change from baseline PR interval will be reported using a linear mixed-effects model analysis. |
Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
|
Placebo-corrected Change From Baseline in QRS interval (ΔΔQRS) for KRP-S124
時間枠:Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
Placebo-corrected change from baseline in QRS interval will be reported using a linear mixed-effects model analysis. |
Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
|
Number of Participants With Categorical Outliers for QTcF, HR, PR and QRS
時間枠:Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
HR, PR, QRS, and QTc will be measured by continuous electrocardiogram (ECG) recordings. Number of participants with categorical outliers for QTcF, HR, PR and QRS will be reported. |
Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
|
Number of Participants With Treatment-emergent Changes in ECG Morphology for KRP-S124
時間枠:Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
|
|
|
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Percentage of AUC0-inf Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (Residual Area) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Residual area will be calculated as [1 - (AUC0-t divided by AUC0-inf)] multiplied by 100. |
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
Maximum Observed Plasma Concentration (Cmax) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Terminal Elimination Half-life (T1/2 el) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Terminal Elimination Rate Constant (Kel) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Apparent Clearance (Cl/F) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Apparent Volume of Distribution (Vz/F) for KRP-S124 and Moxifloxacin
時間枠:Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
|
|
|
Number of Participants With Adverse Events
時間枠:Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
|
|
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values
時間枠:Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Measurements
時間枠:Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
|
|
Number of Participants With Clinically Significant Changes From Baseline in 12-lead Safety ECG Measurements
時間枠:Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
時間枠:Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KRPS124-T101
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?
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
米国FDA規制機器製品の研究
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