- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00605852
Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects
16 de agosto de 2017 atualizado por: GlaxoSmithKline
A Double-blind, Placebo-controlled, Randomized Cross-over Single Dose Escalation Study and a Double-blind, Placebo-controlled, Randomised Parallel Group 7-days Once Daily Repeat Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral H1/H3 Dual Antagonist Compound in Healthy Male Subjects
This study is designed to assess the safety and tolerability of single, escalating oral doses and repeat oral doses (7 days, once daily) of GSK835726 in healthy male subjects
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
A double-blind, placebo controlled, randomized cross-over single dose escalation study and a double-blind, placebo controlled, randomised parallel group 7-days once daily repeat dose study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of oral H1/H3 dual antagonist compound in healthy male subjects
Tipo de estudo
Intervencional
Inscrição (Real)
29
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, NW10 7EW
- 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 50 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion criteria:
- Male aged between 18 and 50 years inclusive.
- Body mass index within the range 19-29kg/m2 (inclusive), with weight range of 55kg-100kg (inclusive).
- Healthy (defined as individuals who are free from significant nasal, cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations).
- Non-smoking status as verified by urinary cotinine levels below 300 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for >1 year.
- Subjects to be entered in cohorts I and III only: Skin prick test reactivity to histamine of 3mm wheal > than saline control and some associated surrounding erythema.
- Subjects to be entered in cohorts I and III only: Negative skin prick test reactivity to saline control.
- The subject is able and willing to give written informed consent to take part in the study and is available to complete all study measurements.
- If sexually active, male subjects must agree to use a condom with spermicide during sexual intercourse, from the first dose of the study drug until 84 days after the last dose. In addition, female partners of male subjects, who are of childbearing potential, must use a reliable contraceptive method or they must refrain from sexual intercourse from the first dose of study medication until 84 days after the last dose. Reliable forms of contraception include an IUD, condom or diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants, contraceptive patches or a tubal ligation."
Exclusion criteria:
- As a result of the medical interview, physical examination or screening investigations, the Investigator or appropriately qualified designee considers the subject unfit for the study.
- The subject has a history of drug or any other allergy, which, in the opinion of the Investigator or appropriately qualified designee, contraindicates their participation, including known or suspected personal history or family history of adverse reactions or hypersensitivity to anti histamines.
- The subject has participated in a study with a new molecular entity during the previous 3 months or any other study during the previous 2 months.
- The subject regularly, or on average, drinks more than 21 units of alcohol a week or more than an average intake of 3 units per day (One unit = 125ml wine or 25ml spirits or 250ml normal strength lager).
- The subject is currently taking regular (or a course of) medication, prescribed (including all anti-allergy medication) or not (including over the counter medication or herbal remedies such as St Johns Wort). Paracetamol is an exception and will be permitted at daily doses of up to 4g following all doses of investigational product.
- The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
- The subject has tested positive for HIV.
- The subject has a positive drugs of abuse and alcohol test.
- Donation of blood (450 mL or more) within 2 months of screening.
- Donation during the study would result in >500mL of blood being donated over a 56 day period
Significant cardiac conduction abnormalities on two or more ECG tracings separated by at least 5 minutes at screening, including:
- QTc interval > 450 msec
- PR interval > 240 msec
- Evidence of second- or third- degree atrioventricular (AV) block
- Ventricular rate < 45 beats per minute (bpm) or > 100 bpm
- Pathological Q-waves (defined as Q-wave > 40 msec or depth greater than 0.4-0.5 mV)
- Evidence of ventricular pre-excitation
- Evidence of left axis deviation, non-specific intraventricular conduction delay (QRS duration > 120 msec), or complete left bundle branch block
- Subjects with Perennial Allergic Rhinitis (PAR) and Seasonal Allergic Rhinitis (SAR), unless subjects with SAR are asymptomatic and it is outside of the pollen season
- Subjects with dermatographism and other skin conditions that might interfere with the wheal and flare test.
- Subjects who are unable to comply with study procedures.
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 |
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Experimental: Subjects receiving treatment in cohort I
Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I.
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GSK835726 will be available in single dose and repeat dose formulations.
Placebo will be given to subjects.
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Experimental: Subjects receiving GSK835726 in cohort II
Eligible subjects will receive repeat doses of GSK835726 once daily for 7 days.
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GSK835726 will be available in single dose and repeat dose formulations.
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Comparador de Placebo: Subjects receiving placebo in cohort II
Eligible subjects will receive repeat doses of placebo once daily for 7 days.
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Placebo will be given to subjects.
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Experimental: Subjects receiving treatment in cohort III
Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III.
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GSK835726 will be available in single dose and repeat dose formulations.
Placebo will be given to subjects.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
Prazo: during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
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during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
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Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts
Prazo: over 24 hours after dosing in single and repeat dose cohorts
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over 24 hours after dosing in single and repeat dose cohorts
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
Prazo: over 24 hours after dosing
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over 24 hours after dosing
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Changes in histamine-induced wheal and flare measurements
Prazo: over 24 hours after dosing
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over 24 hours after dosing
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Derived pharmacokinetic parameters for GSK835726 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-¥)), maximum observed plasma drug concentration (Cmax),
Prazo: over 24 hours after dosing
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over 24 hours after dosing
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time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half life (t1/2) following single and repeat oral dosing.
Prazo: over 24 hours after dosing
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over 24 hours after dosing
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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)
29 de outubro de 2007
Conclusão Primária (Real)
3 de maio de 2008
Conclusão do estudo (Real)
3 de maio de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
18 de janeiro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de janeiro de 2008
Primeira postagem (Estimativa)
31 de janeiro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 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
- HH3110161
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
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Formulário de Relato de Caso Anotado
Identificador de informação: HH3110161Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Relatório de Estudo Clínico
Identificador de informação: HH3110161Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Formulário de Consentimento Informado
Identificador de informação: HH3110161Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de dados de participantes individuais
Identificador de informação: HH3110161Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Plano de Análise Estatística
Identificador de informação: HH3110161Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudo
Identificador de informação: HH3110161Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Especificação do conjunto de dados
Identificador de informação: HH3110161Comentários 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 .
Ensaios clínicos em GSK835726
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GlaxoSmithKlineConcluídoRinite Alérgica SazonalAlemanha
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GlaxoSmithKlineConcluídoRinite Alérgica SazonalAlemanha