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A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed State

23 de janeiro de 2013 atualizado por: Pfizer

A Phase 1, Open Label, Randomized, Single Dose, 5 Period Crossover Relative Bioavailability Study In Healthy Volunteers Evaluating Spray Dried Dispersion (SDD) Immediate Release (IR) PF-06273340 Tablet, Two SDD Modified Release (MR) Matrix Tablets In Comparison With PF-06273340 Oral Solution, Including Preliminary Assessment Of Food Effect

The primary purpose of this study is to estimate the relative bioavailability and food effect of PF-06273340 tablets.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

12

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

      • Singapore, Cingapura, 188770
        • Pfizer 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

21 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Healthy male and/or female subjects of non-child bearing potential, between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
  • Evidence or history of orthostatic hypotension.
  • 12-lead ECG demonstrating QTc >450 or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
  • Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

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
Experimental: PF-06273340 Oral Solution Fasted
Oral solution, single dose, fasted
Immediate Release Tablet, single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fasted
Modified Release Tablet (long duration, MR2), single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fed
Modified Release Tablet (long duration, MR2), single dose, fed
Experimental: PF-06273340 Immediate Release Tablet Fasted
Oral solution, single dose, fasted
Immediate Release Tablet, single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fasted
Modified Release Tablet (long duration, MR2), single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fed
Modified Release Tablet (long duration, MR2), single dose, fed
Experimental: PF-06273340 Modified Release (MR1) Tablet Fasted
Oral solution, single dose, fasted
Immediate Release Tablet, single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fasted
Modified Release Tablet (long duration, MR2), single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fed
Modified Release Tablet (long duration, MR2), single dose, fed
Experimental: PF-06273340 Modified Release (MR2) Tablet Fasted
Oral solution, single dose, fasted
Immediate Release Tablet, single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fasted
Modified Release Tablet (long duration, MR2), single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fed
Modified Release Tablet (long duration, MR2), single dose, fed
Experimental: PF-06273340 Modified Release (MR1) Tablet Fed
Oral solution, single dose, fasted
Immediate Release Tablet, single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fasted
Modified Release Tablet (long duration, MR2), single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fed
Modified Release Tablet (long duration, MR2), single dose, fed
Experimental: PF-06273340 Modified Release (MR2) Tablet Fed
Oral solution, single dose, fasted
Immediate Release Tablet, single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fasted
Modified Release Tablet (long duration, MR2), single dose, fasted
Modified Release Tablet (short duration, MR1), single dose, fed
Modified Release Tablet (long duration, MR2), single dose, fed

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Maximum Observed Plasma Concentration (Cmax)
Prazo: up to 48 h post dose
up to 48 h post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Prazo: up to 48 h post dose
up to 48 h post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Prazo: up to 48 h post dose
up to 48 h post dose
Elimination half life
Prazo: up to 48 h post dose
up to 48 h post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Prazo: up to 48 h post dose
up to 48 h post dose

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 novembro de 2012

Conclusão Primária (Real)

1 de janeiro de 2013

Conclusão do estudo (Real)

1 de janeiro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

11 de outubro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de outubro de 2012

Primeira postagem (Estimativa)

15 de outubro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

24 de janeiro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de janeiro de 2013

Última verificação

1 de janeiro de 2013

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • B5261003

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