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A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954

6 de agosto de 2020 atualizado por: Takeda

A Phase 1, Open-Label, Parallel Group Trial to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single Intravenous Dose of TAK-954

The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

The drug being tested in this study is called TAK-954. This study will evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.

The study will enroll approximately up to 40 participants. Participants will be enrolled in one of the 5 treatment groups based on their renal impairment which will be determined based on Cockcroft and Gault (CG) equation as follows:

  • Group A TAK-954 0.2 mg: Healthy Participants
  • Group B TAK-954 0.2 mg: Mild Renal Impairment
  • Group C TAK-954 0.2 mg: Moderate Renal Impairment
  • Group D TAK-954 0.2 mg: Severe Renal Impairment or End-stage Renal Disease (ESRD) Without Hemodialysis
  • Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) With Hemodialysis

All participants in groups A to D will receive a single dose of TAK-954 and two single doses in Group E.

Enrollment in Group B (Mild) and Group E (ESRD requiring dialysis) will be based on assessment of safety and available PK data from Group C and Group D respectively.

This multi-center trial will be conducted in Czech Republic and Hungary. The overall time to participate in this study is approximately 8 weeks. Participants in Groups A to D will remain confined to clinic for 3 days. For both treatments, participants in Group E requiring dialysis will remain confined to clinic for 3 days. All participants will make a final visit to the clinic 10-14 days after receiving their last dose for a follow-up assessment.

Tipo de estudo

Intervencional

Inscrição (Real)

32

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

      • Budapest, Hungria, 1077
        • PRA Magyarország Kft.
      • Budapest, Hungria, 1115
        • Szent Imre Egyetemi Oktatokorhaz Belgyogyazati Szakmak Matrix Intezet
      • Hradec Kralove, Tcheca, 500 05
        • Fakultni Nemocnice Hradec Kralove
    • Praha
      • Praha 7, Praha, Tcheca, 170 00
        • PRA CZ, s.r.o

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 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. All participants: Male and female participants (non-childbearing potential) who are aged 18 to 75 years, inclusive, with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m^2).
  2. Group A: As much as possible, the healthy participants with normal renal function (creatinine clearance [CLcr] greater than or equal to [>=] 90 milliliter per minute [mL/min]) should be comparable to participants with renal impairment with respect to median age and weight (approximately 50 percent [%] of healthy participants on each side of the median age and weight of currently enrolled renally-impaired participants grouped together), sex, and race. This will be decided by the investigators in discussion with Takeda.
  3. Groups B to E: Participants who have stable RI, defined as no clinically significant change in disease status, as documented by the participant's most recent CLcr assessment; serum creatinine must not vary more than approximately 30% from Screening to Day -1 to confirm stable disease. Participants should also be in good health commensurate with their renal status.

    • Group B: Participants with mild RI (CLcr 60 to less than [<] 90 mL/min).
    • Group C: Participants with moderate RI (CLcr 30 to <60 mL/min).
    • Group D: Participants with severe RI or ESRD but not requiring dialysis (CLcr <30 mL/min).
    • Group E: Participants with ESRD requiring dialysis (<15 mL/min requiring hemodialysis at least 3 times/week, and having been on the same dialysis treatment regimen for at least 1 month before trial entry).
  4. Participants should be on a stable drug regimen defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) before dosing with TAK-954.

Exclusion Criteria:

  1. All participants:

    • Are renal allograft recipients within 1 year of screening.
    • Have a history of gastrointestinal (GI) motility disorder or intestinal obstruction.
    • Have urinary incontinence without catheterization.
  2. Group A: Participants who, in the discretion of the investigator, have a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial.
  3. Groups B to E:

    • Receive dialysis other than intermittent dialysis (except Group E).
    • Have renal disease secondary to hepatic disease (hepatorenal syndrome).
    • At the discretion of the investigators, have any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephrotic.

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: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Group A TAK-954 0.2 mg: Healthy Participants
Participants with normal renal function receive TAK-954 0.2 milligram (mg), infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 infusão intravenosa.
Experimental: Group B TAK-954 0.2 mg: Mild Renal Impairment
Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 infusão intravenosa.
Experimental: Group C TAK-954 0.2 mg: Moderate Renal Impairment
Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 infusão intravenosa.
Experimental: Group D TAK-954 0.2 mg: Severe Renal Impairment
Participants without hemodialysis or End-stage Renal Disease (ESRD) receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 infusão intravenosa.
Experimental: Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD)
Participants with hemodialysis receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period.
TAK-954 infusão intravenosa.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
Prazo: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)
Prazo: Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion
Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)
Prazo: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)
Prazo: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; CLR: Renal Clearance for TAK-954
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 1
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 2
Prazo: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2
Prazo: Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion

Colaboradores e Investigadores

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

Patrocinador

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 (Real)

21 de novembro de 2017

Conclusão Primária (Real)

9 de agosto de 2019

Conclusão do estudo (Real)

9 de agosto de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

25 de setembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de setembro de 2017

Primeira postagem (Real)

28 de setembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de agosto de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2020

Última verificação

1 de agosto de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TAK-954-1007
  • U1111-1196-9206 (Identificador de registro: WHO)
  • 2017-000715-16 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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 .

Ensaios clínicos em Insuficiência renal

Ensaios clínicos em TAK-954

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