A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
2 de agosto de 2017 atualizado por: GlaxoSmithKline
An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male and Female Volunteers.
Study to compare PK of a new 100mg capsule with four 25mg capsules.
This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before.
As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg.
The study will also assess the effect of high fat food on the PK of the 100mg capsule.
The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects.
There will be a week wash out between each dose.
In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state.
Subjects will return to the centre for follow-up 7-14 days after the final dose.
It is expected that the total duration of the study should be approximately eight weeks.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
16
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
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London, Reino Unido, SE1 1YR
- GSK Investigational Site
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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:
- Healthy as determined by responsible physician.
- Male or female between 18 to 65 years old.
- Females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time.
- Males that agree to use appropriate method of contraception for appropriate amount of time.
- Neither too fat nor too thin.
- Capable of giving written informed consent and being compliant with requirements within the informed consent.
Exclusion:
- Any current medical or psychiatric illness.
- Any history of chronic medical or psychiatric illnesses.
- Previous or current alcohol or drug abuse/dependence including nicotine.
- Female subjects must not be breastfeeding or been breastfeeding for a month.
- Serum prolactin exceeding normal range.
- Personal or family history of prolonged QTc syndrome.
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 |
|---|---|
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Experimental: Subjects receiving treatment sequence ABC
Eligible subjects will receive treatment sequence ABC; A= 4x25 milligrams GSK598809 capsule given in fasted state, B= 100 milligrams GSK598809 capsule in given fasted state and C= 100 milligrams GSK598809 capsule given in fed state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
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GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
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Experimental: Subjects receiving treatment sequence ACB
Eligible subjects will receive treatment sequence ACB; A= 4x25 milligrams GSK598809 capsule given in fasted state, C= 100 milligrams GSK598809 capsule given in fed state and B= 100 milligrams GSK598809 capsule in given fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
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|
Experimental: Subjects receiving treatment sequence BAC
Eligible subjects will receive treatment sequence BAC; B= 100 milligrams GSK598809 capsule in given fasted state, A= 4x25 milligrams GSK598809 capsule given in fasted state and C= 100 milligrams GSK598809 capsule given in fed state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Experimental: Subjects receiving treatment sequence BCA
Eligible subjects will receive treatment sequence BCA; B= 100 milligrams GSK598809 capsule in given fasted state, C= 100 milligrams GSK598809 capsule given in fed state and A= 4x25 milligrams GSK598809 capsule given in fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Experimental: Subjects receiving treatment sequence CAB
Eligible subjects will receive treatment sequence CAB; C= 100 milligrams GSK598809 capsule given in fed state, A= 4x25 milligrams GSK598809 capsule given in fasted state and B= 100 milligrams GSK598809 capsule in given fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Experimental: Subjects receiving treatment sequence CBA
Eligible subjects will receive treatment sequence CBA; C= 100 milligrams GSK598809 capsule given in fed state, B= 100 milligrams GSK598809 capsule in given fasted state and A= 4x25 milligrams GSK598809 capsule given in fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
Prazo: Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours
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Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Safety and Tolerability: cardiovascular variables, vital signs, clinical labs, movement scales, prolactin, GH and TSH levels over 96 hours post dosing. Continuous adverse event monitoring from dosing until study conclusions.
Prazo: Up to 96 hours
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Up to 96 hours
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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)
2 de julho de 2008
Conclusão Primária (Real)
29 de julho de 2008
Conclusão do estudo (Real)
29 de julho de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
4 de agosto de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de agosto de 2008
Primeira postagem (Estimativa)
6 de agosto de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de agosto de 2017
Última verificação
1 de agosto de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DAN111283
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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