- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00613431
Effects of CS-8080 in Healthy Volunteers
19 de dezembro de 2018 atualizado por: Daiichi Sankyo, Inc.
A Randomized, Placebo-Controlled, Single Ascending Dose Study To Assess The Safety, Tolerability and Pharmacokinetics Of CS-8080 In Healthy Volunteers
The main purposes of this study are to assess the safety and measure the pharmacokinetics of CS-8080 in healthy volunteers.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
72
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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New Jersey
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Neptune, New Jersey, Estados Unidos, 07753
- MDS Pharma Services
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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 45 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria Healthy men and/or women, aged 18 to 45 years inclusive.
- Women must be of non-child bearing potential, ie, either:Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing), or Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with an FSH level at screening of > 40 mIU/mL.
- All women must have a negative serum pregnancy test at screening and within 48 hours before dosing.
- Body Mass Index (BMI) of 19 to 30 kg/m2 inclusive.
- Good health as determined by the absence of clinically significant deviation from normal, based on medical history, physical examination, laboratory reports, and 12 lead ECG, as deemed by the Investigator, prior to enrollment.
- Able to understand and willing to comply with all study requirements, and willing to follow the study medication regimen.
- Willing and able to give a written informed consent.
- Negative urine test for drugs of abuse and alcohol at screening and check-in.
- Negative result for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody at screening.
Exclusion Criteria
- Any history of drug abuse.
- History of alcohol addiction during the 2 years prior to Day 1.
- History of significant allergic response to any drug except penicillin.
- History or current evidence, as determined by the Investigator, of psychiatric or emotional problems which would invalidate giving informed consent or limit the ability of the subject to comply with study requirements.
- History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal (ie, any condition which may affect drug absorption), hematologic, or oncologic disease as determined by the Investigator after reviewing screening history, physical examination, laboratory test results, and 12-lead ECG.
- History or current alcoholic or non-alcoholic liver disease or liver steatosis.
- History of prostate disease or prostatitis.
- Subjects with a history of congenital Long QT Syndrome (LQTS), a history of surviving a near-drowning episode, or a history of any form of syncope or loss of consciousness.
- Subjects with QTc interval duration >450 msec obtained as an average from the ECG machine readings on the triplicate ECG (3 readings in rapid succession and not more than 2 minutes apart) taken at screening, after at least 10 minutes of quiet rest in a supine position.
- Subjects with abnormal ECG waveform morphology on any of the ECGs from the screening triplicate that would preclude accurate manual measurement of the QT interval duration.
- Need for any concomitant medication.
- Prestudy medication use as specified in Section 6.2.1.
- Consumption of any food or beverages containing grapefruit from 7 days prior to Day 1 through study completion.
- Consumption of foods or beverages containing alcohol from 24 hours before check-in through discharge from the clinic.
- Blood donation or significant blood loss within the 56 days before Day -1.
- Plasma donation within 7 days before Day -1.
- Participation in another investigational new drug research study within the 30 days before Day 1.
- Use of tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within the 6 months before Day 1.
- Relationship of the subject to the Investigator, any sub-investigator, pharmacist, study coordinator, or other staff directly involved in the conduct of the study, or employment by the Sponsor or contract research organization participating in the study.
- Screening laboratory values outside the range of normal values deemed clinically significant by the Investigator. Serum lipid tests, triglycerides, cholesterol (LDL, HDL and total cholesterol), liver function tests (ALT, AST, GGT, total bilirubin, LDH and ALP) and PSA must not exceed the upper limit of normal without permission of the Sponsor.
- Hemoglobin <12.0 g/dL at the screening visit.
- Shift work, defined as any work shifts, either regular or irregular, precluding sleep during the hours of 10 pm and 6 am, within 1 week prior to Day -2, and no more than 2 works shifts per week meeting the above criteria from 4 to 1 week prior to Day -2.
- Positive fecal occult blood test at screening.
- Familial relationship with any other study participant.
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 Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 1
6 dose groups, 9 subjects on active, 3 subjects on placebo in each group
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CS-8080 tablets will be administered once daily at doses of 1, 3, 10, 20, 50 and 100 mg.
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Comparador de Placebo: 2
3 subjects on placebo in each group
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Some subjects will receive matching placebo instead of CS-8080.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Safety assessed over the 5-day post-dose inpatient period and at a follow-up 1 week post-discharge.
Prazo: 2 weeks
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2 weeks
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Single dose plasma pharmacokinetics of CS-8080
Prazo: 2 weeks
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2 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Pharmacodynamic response to CS-8080, as assessed by mRNA levels to 24 h post-dose.
Prazo: 2 weeks
|
2 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Robert Noveck, MD, MDS Pharma Services
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
1 de janeiro de 2008
Conclusão Primária (Real)
1 de agosto de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
31 de janeiro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de fevereiro de 2008
Primeira postagem (Estimativa)
13 de fevereiro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de dezembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de dezembro de 2018
Última verificação
1 de dezembro de 2008
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- CS8080-A-U101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Prazo de Compartilhamento de IPD
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Critérios de acesso de compartilhamento IPD
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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 .