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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

31 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Quebec
      • Québec, Quebec, Canada
        • Reclutamento
        • Syneos Health

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Sperimentale: 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.

Sperimentale: Treatment ST2 (Supratherapeutic Dose 2)

Participants will receive a single oral dose of Supratherapeutic dose 2 (ST2) (KRP-S124 [high dose]).

Orally.

Comparatore placebo: Treatment P (Placebo)

Participants will receive a single oral dose of placebo matched to KRP-S124.

Orally.

Comparatore attivo: Treatment M (Moxifloxacin)

Participants will receive a single oral dose of moxifloxacin (M).

Orally.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Placebo-corrected Change From Baseline in Fridericia's Corrected QT interval (delta delta [ΔΔ]QTcF) for KRP-S124
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Placebo-corrected Change From Baseline in Heart Rate (ΔΔHR) for KRP-S124
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values
Lasso di tempo: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Measurements
Lasso di tempo: 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
Lasso di tempo: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Lasso di tempo: Up to approximately 10 weeks
Up to approximately 10 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 ottobre 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

12 febbraio 2027

Date di iscrizione allo studio

Primo inviato

31 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 ottobre 2026

Primo Inserito (Effettivo)

5 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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