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- Ensaio Clínico NCT07919314
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Clinical Development Center Kyorin Pharmaceutical Co., Ltd.
- Número de telefone: +81-3-6368-4834
- E-mail: ml-kyorin_clinicaltrials.gov@mb.kyorin-pharm.co.jp
Locais de estudo
-
-
Quebec
-
Québec, Quebec, Canadá
- Recrutamento
- Syneos Health
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: Treatment ST2 (Supratherapeutic Dose 2)
Participants will receive a single oral dose of Supratherapeutic dose 2 (ST2) (KRP-S124 [high dose]). |
Orally. |
|
Comparador de Placebo: Treatment P (Placebo)
Participants will receive a single oral dose of placebo matched to KRP-S124. |
Orally. |
|
Comparador Ativo: Treatment M (Moxifloxacin)
Participants will receive a single oral dose of moxifloxacin (M). |
Orally. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Placebo-corrected Change From Baseline in Fridericia's Corrected QT interval (delta delta [ΔΔ]QTcF) for KRP-S124
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Placebo-corrected Change From Baseline in Heart Rate (ΔΔHR) for KRP-S124
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
|
|
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values
Prazo: Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Measurements
Prazo: 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
Prazo: Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Prazo: Up to approximately 10 weeks
|
Up to approximately 10 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KRPS124-T101
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