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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

2026年10月31日 更新者:Kyorin Pharmaceutical Co.,Ltd

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

研究の種類

介入

入学 (推定)

40

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。

研究連絡先

研究場所

    • Quebec
      • Québec、Quebec、カナダ
        • 募集
        • Syneos Health

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:

  • 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

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: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

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)

2026年10月14日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年2月12日

試験登録日

最初に提出

2026年10月31日

QC基準を満たした最初の提出物

2026年10月31日

最初の投稿 (実際)

2026年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年10月31日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

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?

いいえ

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

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