The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
6 de maio de 2016 atualizado por: Pfizer
A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers
The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
37
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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Michigan
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Kalamazoo, Michigan, Estados Unidos, 49007
- Jasper Clinic, Inc.
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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 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Healthy male or females willing to be confined and comply with scheduled visits
- Women are to be surgically sterile.
Exclusion Criteria:
- History of febrile illness within 5 days prior to the first dose
- Positive urine drug screen
- Treatment with an investigational product within 30 days prior to the first dose of study medication
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
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
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Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
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Outro: Sequence B
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
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Outro: Sequence C
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
Outro: Sequence D
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
Outro: Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
|
Outro: Sequence F
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
Outro: Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
Prazo: 8 days
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The change in serum osteocalcin from baseline after treatment on Day 1 and Day 8 will be assessed in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
Prazo: 8 days
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Change from baseline in serum cortisol after treatment on Day 1 and Day 8 in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression
Prazo: 14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
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Serum cortisol in response to low-dose ACTH Stimulation Test will be completed at the end of Period 3 for each subject
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14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts
Prazo: 8 days
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Change from baseline in blood leukocytes (neutrophils, lymphocytes and eosinophils) in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP)
Prazo: 8 days
|
The change from baseline in serum P1NP after treatment on Day 1 and Day 8 will be assessed in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary N-terminal cross-linked telopeptide of type 1 collagen (uNTX-1)
Prazo: 8 days
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Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin
Prazo: 8 days
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Glucose and insulin will be assessed for the change from baseline after 7 days of treatment on Day 8 in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test
Prazo: Day 6
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On Day 6 of each period, subjects will undergo an oral glucose tolerance test.
After ingesting 75 g of a glucose solution within 5 minutes of receiving their daily dose of prednisone, blood samples for glucose were obtained at 0.5, 1 and 2 hours.
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Day 6
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides
Prazo: 8 days
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Change from baseline in triglycerides will be assessed after 7 days of treatment on Day 8 in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression
Prazo: 7 days
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Change from baseline in 24-hour urinary cortisol on Day 7 in each treatment period
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7 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin
Prazo: 8 days
|
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
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8 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
Prazo: 7 days
|
Change from baseline after 7 days of treatment in each treatment period.
The POMS is a copyrighted questionnaire that measures 6 dimensions of mood.
The subject will assess how 65 descriptors apply to him/her on a 5-point scale of 0 (not at all) to 4 (extremely).
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7 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)
Prazo: 7 days
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Change from baseline in sleep after 7 days of treatment will be assessed in each treatment period.
The patient-reported questionnaire consists of 12 items that assesses the key constructs of sleep.
Scores can range from 12-71 with higher number indicating more problems with sleep.
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7 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events
Prazo: 28 days after last dose of study medication in Period 3
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Subjects were monitored throughout the study and queried for adverse events
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28 days after last dose of study medication in Period 3
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure
Prazo: 8 days
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Blood pressure will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight
Prazo: 8 days
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A post-void weight will be collected on the morning of Day 1 and Day 8 to assess change from baseline during each treatment period.
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8 days
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate
Prazo: 8 days
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Pulse rate will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
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8 days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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 outubro de 2005
Conclusão Primária (Real)
1 de março de 2006
Conclusão do estudo (Real)
1 de março de 2006
Datas de inscrição no estudo
Enviado pela primeira vez
21 de abril de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de maio de 2016
Primeira postagem (Estimativa)
10 de maio de 2016
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
10 de maio de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de maio de 2016
Última verificação
1 de maio de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- A9001309
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 .