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A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults

28 de maio de 2026 atualizado por: AstraZeneca

A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat/Ezetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults

The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a randomized, open-label, 4-period, single-dose, cross-over study.

The study will comprise of a screening period, 4 treatment periods, and 3 washout periods. The following treatments will be given during the study:

  • Treatment A: laroprovstat/ezetimibe fixed combination drug product (FCDP) test formulation in fasted state
  • Treatment B: laroprovstat tablet plus ezetimibe reference formulations in fasted state
  • Treatment C: laroprovstat/ezetimibe FCDP test formulation in fed state
  • Treatment D: laroprovstat/ezetimibe FCDP test formulation-slow variant in fasted state

Participants will be randomly assigned to either of the 3 treatment sequences: ABCD, BCAD, or CABD.

Tipo de estudo

Intervencional

Inscrição (Estimado)

18

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Maryland
      • Brooklyn, Maryland, Estados Unidos, 21225
        • Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Healthy male and female participants aged 18 to 55 years at the time of signing consent.
  • All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.
  • Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
  • Have a Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.

Exclusion Criteria:

  • History of any clinically important disease or disorder.
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to laroprovstat or ezetimibe.
  • Treatment with any lipid lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.
  • Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit or inclisiran at any time.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Treatment A
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state.
Medicamento: Laroprovstat/ezetimibe FCDP
Laroprovstat/ezetimibe will be administered orally.
Experimental: Treatment B
Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state.
Medicamento: Laroprovstat STP
Laroprovstat will be administered orally.
Medicamento: Ezetimibe STP
Ezetimibe will be administered orally.
Experimental: Treatment C
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state.
Medicamento: Laroprovstat/ezetimibe FCDP
Laroprovstat/ezetimibe will be administered orally.
Experimental: Treatment D
Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state.
Medicamento: Laroprovstat/ezetimibe FCDP-slow variant
Laroprovstat/ezetimibe slow variant will be administered orally

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Area under concentration-time curve from time 0 to infinity (AUCinf)
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Maximum observed drug concentration (Cmax)
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Plasma Time to reach maximum observed concentration (tmax)
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the pharmacokinetic (PK) profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Terminal elimination half-life (t½λz)
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Apparent total body clearance (CL/F)
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Apparent volume of distribution based on the terminal phase (Vz/F)
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUCinf
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUClast
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Cmax
Prazo: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

10 de junho de 2026

Conclusão Primária (Estimado)

7 de setembro de 2026

Conclusão do estudo (Estimado)

7 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

28 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de maio de 2026

Primeira postagem (Real)

3 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D7963C00001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Prazo de Compartilhamento de IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critérios de acesso de compartilhamento IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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