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A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

12 de maio de 2017 atualizado por: GlaxoSmithKline

A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.

Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.

Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.

Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

54

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

  • Reino Unido
    • Middlesex
      • Harrow, Middlesex, Reino Unido, HA13UJ
        • GSK Investigational 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

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Subject is positive at screening for HAVH autoantibodies against GSK1995057 (Part 1 only).
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study drug/alcohol screen.
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Exclusion Criteria:

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study drug/alcohol screen.
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day

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 de grupo único
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Part 1: Cohort 1a
Single IV dose of GSK2862277 as a continuous infusion over 2 hours.
Medicamento: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 1: Cohort 1b
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.
Medicamento: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 1: Cohort 1c
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.
Medicamento: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 2: Cohort 2a GSK2862277
Single IV dose of GSK2862277 as a continuous infusion over 1 hour.
Medicamento: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 2: Cohort 2a Placebo
Matching placebo will be administered as a continuous IV infusion over 1 hour.
Medicamento: Matching placebo single dose IV infusion
Matching placebo solution available for IV administration.
Experimental: Part 2: Cohort 2b GSK2862277
Single IH dose of GSK2862277.
Medicamento: Single IH dose of GSK2862277
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
Experimental: Part 2: Cohort 2b Placebo
Matching placebo will be administered.
Medicamento: Matching placebo single dose IH
Matching placebo nebulised solution available for IH administration.
Experimental: Part 3: Cohort 3a GSK2862277
IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days.
Medicamento: Repeat IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 3: Cohort 3a Placebo
Matching placebo will be administered as IV infusion over 1 hour daily for 5 days.
Medicamento: Matching placebo repeat dose IV infusion
Matching placebo solution available for IV administration.
Experimental: Part 3: Cohort 3b GSK2862277
Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days.
Medicamento: Repeat IH dose selected of GSK2862277 from Part 2
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
Experimental: Part 3: Cohort 3b Placebo
Matching placebo will be administered as IH daily for 5 days.
Medicamento: Matching placebo repeat dose IH
Matching placebo nebulised solution available for IH administration.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by number of subjects with adverse events (AE)s in Part 1 and Part 2
Prazo: Up to 42 days
Safety and tolerability parameters will include recording of adverse events (AEs), throughout the study.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by number of subjects with AEs in Part 3
Prazo: Up to 42 days
Safety and tolerability parameters will include recording of AEs, throughout the study.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by laboratory tests in Part 1 and Part 2
Prazo: Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 as assessed by laboratory tests in Part 3
Prazo: Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by vital signs in Part 1 and Part 2
Prazo: Up to 42 days
Vital signs will include blood pressure (BP), heart rate respiration rate and body temperature.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by vital signs in Part 3
Prazo: Up to 42 days
Vital signs will include BP, heart rate respiration rate and body temperature.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by ECG in Part 1 and Part 2
Prazo: Up to 42 days
Safety data will include electrocardiogram (ECG) readings obtained at each timepoint during the study.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by ECG in Part 3
Prazo: Up to 42 days
Safety data will include ECG readings obtained at each timepoint during the study.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 1 and Part 2
Prazo: Up to 42 days
Spirometry monitoring will include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 3
Prazo: Up to 42 days
Spirometry monitoring will include FEV1 and FVC.
Up to 42 days
Safety and tolerability of single IV dose of GSK2862277 as assessed by measurement of plasma cytokines in Part 1
Prazo: Up to 42 days
Blood samples will be collected for assessment of plasma cytokines.
Up to 42 days
Immunogenicity in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Prazo: Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
Up to 60 days
Immunogenicity in subjects receiving repeat IV or IH dose of GSK2862277 in Part 3
Prazo: Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
Up to 60 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pharmacokinetic (PK) parameters in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Prazo: Up to 48 hours post dose
The blood samples will be collected for plasma concentrations of GSK2862277.
Up to 48 hours post dose
PK parameters in subjects receiving repeat IV dose of GSK2862277 in Part 3 Cohort 3a
Prazo: Up to 48 hours post last dose
The blood samples will be collected for plasma concentrations of GSK2862277.
Up to 48 hours post last dose
PK parameters in subjects receiving repeat IH dose of GSK2862277 in Part 3 Cohort 3b
Prazo: Up to 48 hours post last dose
The blood samples will be collected for plasma concentrations of GSK2862277
Up to 48 hours post last dose
PK parameters in subjects receiving single IV dose of GSK2862277 in Part 1
Prazo: Up to 48 hours post last dose
The PK parameters will be compared with historic GSK1995057 PK data in Part 1
Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Prazo: Up to 48 hours post last dose
The pharmacodynamic and immune function biomarkers in serum.
Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving repeat IV or IH dose of GSK2862277in Part 3
Prazo: Up to 48 hours post last dose
The pharmacodynamic and immune function biomarkers in serum.
Up to 48 hours post last dose
Change from baseline in IL-8 expression in ex vivo WBA in subjects receiving single IV 0.05 mg/kg dose of GSK2862277 in Part 1 in Cohort1c
Prazo: Up to 12 hours post dose
IL-8 expression in ex vivo whole blood essay (WBA).
Up to 12 hours post dose
Composite of urine parameters in subjects receiving single IV 2 mg/kg dose of GSK2862277 in Part 2 in Cohort 2a
Prazo: Up to 48 hours post dose
The urine samples will be collected for urine concentrations of GSK2862277.
Up to 48 hours post dose

Colaboradores e Investigadores

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

Patrocinador

GlaxoSmithKline

Publicações e links úteis

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Publicações Gerais

Links úteis

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)

22 de fevereiro de 2013

Conclusão Primária (Real)

25 de outubro de 2013

Conclusão do estudo (Real)

25 de outubro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

14 de fevereiro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de março de 2013

Primeira postagem (Estimativa)

26 de março de 2013

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de maio de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de maio de 2017

Última verificação

1 de maio de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 116343

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dados/documentos do estudo

  1. Especificação do conjunto de dados
    Identificador de informação: 116343
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Conjunto de dados de participantes individuais
    Identificador de informação: 116343
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Relatório de Estudo Clínico
    Identificador de informação: 116343
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulário de Relato de Caso Anotado
    Identificador de informação: 116343
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulário de Consentimento Informado
    Identificador de informação: 116343
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plano de Análise Estatística
    Identificador de informação: 116343
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  7. Protocolo de estudo
    Identificador de informação: 116343
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register

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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