- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00500201
A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets.
5 de agosto de 2017 atualizado por: GlaxoSmithKline
A Single Blind, Double Dummy, Placebo Controlled, Randomized, 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers
Study to compare PK of a new 120mg tablet with two 60mg tablets.
This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before.
As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients.
The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects.
There will be 20 days washout between each dose.
Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo.
If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed.
If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped.
Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
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.
Locais de estudo
-
-
-
London, Reino Unido, NW10 7NS
- 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 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- be a healthy man or woman, aged 18 to 55, and be neither too fat nor too thin;
- If you are a woman who can have a baby, you must use an acceptable method of contraception, from the start of your last period before you take the study medicine, until you've had your first normal period after the end of the study. You might need to use contraception for longer than that. You don't need to use contraception if your partner has been sterilized (had an operation to cut the tubes that carry sperm).
- Acceptable methods of contraception for women are:
- Diaphragm or cap and condom with spermicide;
- the 'Pill' and condom with spermicide - you must have been taking the 'Pill' for at least 3 months before the start of the study;
- Intrauterine device (IUD or 'coil' - your GP must confirm that you have one) and condom with spermicide; or
- Condom and spermicide only, if you're a woman who has had an operation to have your tubes tied.
- If you are a woman who CANNOT have a baby, you should have gone through menopause at least 1 year ago;
- had your womb removed; or
- had both ovaries removed.
- have normal physical exam
- have normal blood pressure and pulse.
- be able to swallow tablets;
- show proof of identity - we'll tell you what's suitable.
- have the ability to understand and comply with protocol requirements, instructions and restrictions.
- be available to attend the ward for repeat tests, if necessary, during the 2 weeks after your final planned visit.
Exclusion Criteria:
- abuse alcohol or drugs;
- drink, on average, more than 3 units of alcohol daily if you're a man, or 2 units if you're a woman (1 unit = ½ pint of beer, 1 small glass of wine or 1 measure of spirits);
- have been a blood donor in the last 3 months;
- have been given an experimental medicine in the last 3 months;
- have taken part in a study of an experimental medicine in the last 3 months;
- be a smoker, or have smoked cigarettes or used other tobacco products regularly in the last 6 months - we may test your breath for smoking at any time during the study;
- be pregnant or breast feeding;
- have had a serious reaction to any medicine;
- have any screening test results that show you're not suitable, even if they don't mean that you're unhealthy;
- have had any important illness (including diabetes and asthma) that, in the opinion of the study doctor, makes you unsuitable for the study;
- have had any mental illnesses;
- suffer from numbness or tingling in your arms, legs, hands or feet; or
- has had glaucoma (increased pressure inside the eye).
- You may not be able to take part if you've taken any medicines recently, including herbal remedies like St John's wort.
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
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Subjects in treatment sequence AB
In treatment sequence AB first subjects will be randomized to receive treatment A (two tablets of 60 milligram [mg] of SB-773812) and one placebo tablet.
Then subjects will receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets .
There will be a wash-out period of 20 days between.
|
SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
Outros nomes:
SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
Placebo tablets will be administered orally by subjects.
|
|
Experimental: Subjects in treatment sequence BA
In treatment sequence BA first subjects will be randomized to receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets.
Then subjects will receive treatment A (two tablets of 60 mg of SB-773812) and one placebo tablet.
There will be a wash-out period of 20 days between.
|
SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
Outros nomes:
SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
Placebo tablets will be administered orally by subjects.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions.
Prazo: 336 hrs post SB773812 dosing
|
336 hrs post SB773812 dosing
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Safety: ECG, vital signs, clinical labs over 336 hours post SB-773812 dosing in both dosing sessions.
Prazo: 336 hours post SB-773812 dosing
|
336 hours post SB-773812 dosing
|
|
Continuous adverse event monitoring from dosing until study conclusion and follow up, 7-14days after last dose.
Prazo: 7-14days after last dose
|
7-14days after last dose
|
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)
24 de maio de 2007
Conclusão Primária (Real)
25 de julho de 2007
Conclusão do estudo (Real)
25 de julho de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
10 de julho de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2007
Primeira postagem (Estimativa)
12 de julho de 2007
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 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
- NAA105737
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 .