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A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers

29 de maio de 2018 atualizado por: Biota Scientific Management Pty Ltd

A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Vapendavir (BTA798) on the Pharmacokinetics of Orally Administered Midazolam, a CYP3A4 Substrate, in Healthy Male and Female Volunteers

The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

24

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.

Locais de estudo

  • Estados Unidos
    • Minnesota
      • Saint Paul, Minnesota, Estados Unidos, 55114
        • Prism Clinical Research

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

18 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening;
  • Capable of giving written informed consent;
  • Subject is able to understand and comply with the protocol requirements, instructions and restrictions;
  • Healthy on the basis of physical examination, medical history, medication usage, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;
  • Female subjects who are not post-menopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as a condom plus spermicidal agent (foam/gel/film/cream/suppository); and
  • Female subjects must not be breastfeeding or pregnant.

Exclusion Criteria:

  • Positive results for Hepatitis B, Hepatitis C, or HIV;
  • Frequent use (defined as > 5 times/day) of tobacco products, including cigarettes, cigars, chewing tobacco;
  • A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event;
  • Current or recent respiratory infection (defined as within 14 days of first study visit participation)
  • Presence or history of significant allergy;
  • Clinically significant abnormalities noted on ECG;
  • Screening vital signs representing sustained elevated systolic blood pressure <90 mmHg or >140 mmHg, and/or diastolic blood pressure <55 mmHg or >90 mmHg.
  • Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;
  • Safety laboratory abnormalities noted at screening which are clinically significant
  • Current or defined history of abuse of alcohol or illicit drugs;
  • A positive pregnancy test at screening;
  • Poor vein access or fear of venipuncture or sight of blood; and
  • Regular consumption of alcohol defined as either > 2 units (glass or shot) of alcoholic beverages per day or > 14 units per week.

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: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Vapendavir 528 mg QD
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
Medicamento: Midazolam 5mg Syrup

All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.

  • On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
  • On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.
Medicamento: Vapendavir 528 mg QD
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
Experimental: Vapendavir 264 mg BID
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.
Medicamento: Midazolam 5mg Syrup

All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.

  • On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
  • On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.
Medicamento: Vapendavir 264 mg BID
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Effect of Vapendavir on the PK Profile of Midazolam
Prazo: End of Study (up to 46 weeks in duration)

To evaluate the effect of vapendavir daily dose of 264 mg BID on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:

  • for midazolam including maximum observed plasma concentration (Cmax)
  • time at which Cmax was observed (Tmax)
  • plasma concentration at the end of the dosing interval (Ctau)
  • area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
  • area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
  • area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
  • elimination half-life (t1/2)
  • apparent oral clearance (CL/F)
  • apparent oral volume of distribution (Vz/F).
End of Study (up to 46 weeks in duration)
The Effect of Vapendavir on the PK Profile of Midazolam
Prazo: End of Study (up to 46 weeks in duration)

To evaluate the effect of vapendavir daily dose of 528 mg QD on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:

  • for midazolam including maximum observed plasma concentration (Cmax)
  • time at which Cmax was observed (Tmax)
  • plasma concentration at the end of the dosing interval (Ctau)
  • area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
  • area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
  • area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
  • elimination half-life (t1/2)
  • apparent oral clearance (CL/F)
  • apparent oral volume of distribution (Vz/F).
End of Study (up to 46 weeks in duration)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Assess Whether PK Profile of Vapendavir is Affected by Presence of Midazolam
Prazo: End of Study (up to 46 weeks in duration)

To evaluate whether the PK profile of vapendavir, is affected by the presence of midazolam, a strong CYP3A4 substrate. This outcome will be evaluated through a series of analyses of PK parameters for vapendavir including:

  • maximum observed plasma concentration (Cmax)
  • time at which Cmax was observed (Tmax)
  • plasma concentration at the end of the dosing interval (Ctau)
  • area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
  • area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
  • area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
  • elimination half-life (t1/2)
  • apparent oral clearance (CL/F)
  • apparent oral volume of distribution (Vz/F).
End of Study (up to 46 weeks in duration)
Assess the Safety of Vapendavir
Prazo: End of Study (up to 46 weeks in duration
To evaluate the safety of vapendavir. This will be accomplished by assessing adverse events, clinical laboratory tests (including blood chemistry, hematology with differential and urinalysis), physical exams, ECG assessments, vital sign assessments and concomitant medications.
End of Study (up to 46 weeks in duration

Colaboradores e Investigadores

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

Patrocinador

Biota Scientific Management Pty Ltd

Investigadores

  • Investigador principal: Mark Matson, MD, Prism Clinical Research

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

1 de maio de 2014

Conclusão Primária (Real)

1 de junho de 2014

Conclusão do estudo (Real)

1 de junho de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de julho de 2014

Primeira postagem (Estimativa)

30 de julho de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de maio de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2018

Última verificação

1 de maio de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BTA798-102

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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