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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02292433
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
16 de fevereiro de 2016 atualizado por: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled, 3- Period, Crossover Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Two Dose Levels of Pf-04937319 In Japanese Subjects With Type 2 Diabetes Mellitus as Monotherapy
Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
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
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Tokyo
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Hachioji-shi, Tokyo, Japão, 192-0071
- P-one clinic, Keikokai medical corporation
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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
20 anos a 64 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)
Exclusion Criteria:
- Patients with cardiovascular event
- Patients with diabetic complications
- Female subjects who are pregnant or planning to become pregnant
- Subjects with unstable medical conditions (eg, hypertension)
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: PF-04937319
PF-04937319 Split dose
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tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days
tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days
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Comparador de Placebo: Placebo
Placebo split dose
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tablets, breakfast plus lunch, 7 days
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Prazo: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
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Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
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Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)
Prazo: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
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A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels.
HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.
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Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
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Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1
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AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1
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Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose) on Day 7
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Ctrough is the concentration prior to study drug administration.
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0 hour (pre-dose) on Day 7
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Average Plasma Concentration (Cav) on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Cav is the average plasma concentration during the 0 to 24 hour time period.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Apparent Oral Clearance on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability.
It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Terminal Half-Life (t1/2) on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Only those data points judged to describe the terminal log-linear decline were used in the regression.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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Apparent Volume of Distribution on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose is influenced by the oral bioavailability.
It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Accumulation Ratio (Rac) on Day 7 for PF-04937319
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Rac is based on AUC24.
It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF--06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
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Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF--06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF--06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF--06455349
Prazo: 0 hour (pre-dose) on Day 7
|
Ctrough is the concentration prior to study drug administration.
PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose) on Day 7
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Average Plasma Concentration (Cav) on Day 7 for PF--06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Cav is the average plasma concentration during the 0 to 24 hour time period.
PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Terminal Half-Life (t1/2) on Day 7 for PF-06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) * 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Only those data points judged to describe the terminal log-linear decline were used in the regression.
PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
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Accumulation Ratio (Rac) on Day 7 for PF-06455349
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Rac is based on AUC24.
It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7
Prazo: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
PF-06455349 is a metabolite of PF-04937319.
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0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7
Prazo: Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7
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WMDG was defined as time-weighted mean daily glucose.
WMDG was calculated by as the time-weighted mean of glucose levels at actual time points for glucose sampling, for Day 0 (Baseline) and Day 7.
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Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7
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Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment
Prazo: Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8
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FPG was defined as plasma glucose measurements taken pre-breakfast, in the fasted state, and prior to dosing with study drug.
Baseline was defined as the average of Hour 0 measurements taken on Day 0 and Day 1 in each intervention period.
The measurement on the last day of treatment was defined as the average of Hour 0 measurements taken on Day 7 and Day 8 in each period.
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Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8
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Change From Baseline in Pre-Meal Insulin at Day 7
Prazo: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
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Time-matched change from baseline in pre-meal serum insulin on Day 7 of each period was analyzed.
Pre-meal insulin levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.
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Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
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Change From Baseline in Pre-Meal C-Peptide at Day 7
Prazo: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
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Time-matched change from baseline in pre-meal serum C-peptide on Day 7 of each period was analyzed.
Pre-meal C-peptide levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.
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Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
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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 janeiro de 2015
Conclusão Primária (Real)
1 de março de 2015
Conclusão do estudo (Real)
1 de março de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
12 de novembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de novembro de 2014
Primeira postagem (Estimativa)
17 de novembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
15 de março de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de fevereiro de 2016
Última verificação
1 de fevereiro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B1621018
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 .
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