Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers
11 de dezembro de 2018 atualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of JNJ-28431754 in Otherwise Healthy Obese Male and Female Subjects
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of canagliflozin (JNJ-28431754) in healthy obese volunteers.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This study will be a single-center, randomized (the treatment is assigned by chance), double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), ascending multiple dose study (increasing doses of study medication) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in otherwise healthy obese volunteers.
The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up) phase.
Volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy obese men and women.
Within each group, 12 volunteers will be given canagliflozin once or twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily for 14 days.
The dose of canagliflozin will be different for each of the 5 groups and the second group will not begin treatment until at least 21 days after the first group start treatment.
This 21-day gap will be applied to all subsequent groups.
Each volunteer will participate in the study for approximately 58 days.
Tipo de estudo
Intervencional
Inscrição (Real)
80
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
-
-
Florida
-
Miramar, Florida, Estados Unidos
-
-
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 60 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) of 30.0 to 39.9 kg/m2
- Volunteers must be non-diabetic as confirmed by fasting plasma glucose <126 mg/dL
- Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening)
Exclusion Criteria:
- History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
- History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study
- History of gastric banding, gastric bypass or other gastric-reduction surgery
- History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment
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 de grupo único
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Cohort 1
Each volunteer will receive a total daily dose of 30 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Outros nomes:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Experimental: Cohort 2
Each volunteer will receive a total daily dose of 100 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Outros nomes:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Experimental: Cohort 3
Each volunteer will receive a total daily dose of 300 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Outros nomes:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Experimental: Cohort 4
Each volunteer will receive a total daily dose of 600 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Outros nomes:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Experimental: Cohort 5
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) twice daily (600 mg total daily dose) or placebo (inactive medication) twice daily on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Outros nomes:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in urine glucose excretion per day
Prazo: Day -1 (Baseline) up to Day 17
|
The change from baseline in urine excretion per day will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 17
|
|
Change from baseline in urine glucose excretion per hour
Prazo: Day -1 (Baseline) up to Day 17
|
The change from baseline in urine excretion per hour will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 17
|
|
Visual analog scale (VAS) scores related to hunger, satiety, fullness and prospective food consumption
Prazo: Day -2 up to Day 17
|
Visual analog scale (VAS) scores will be obtained from the VAS questionnaire.
In the VAS questionnaire, volunteers mark a point on a line (drawn between 2 statements) to indicate how they feel about the statements.
The statements about hunger are as follows: "I am not hungry at all" and "I have never been hungrier".
Other statements relate to satiety (feeling satisfied), feeling full and prospective food consumption.
Scores will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -2 up to Day 17
|
|
Change from baseline in mean 24-hour plasma glucose concentrations
Prazo: Day -1 (Baseline) up to Day 16
|
The change from baseline in mean 24-hour plasma glucose concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 16
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Renal threshold for glucose excretion
Prazo: Up to Day 17
|
The point at which glucose starts to appear in the urine is known as the renal threshold.
The way in which the renal threshold varies in relation to the dose of canagliflozin (JNJ-28431754) will be calculated.
|
Up to Day 17
|
|
Change from baseline in mean 24-hour plasma insulin concentrations
Prazo: Day -1 (Baseline) up to Day 14
|
The change from baseline in mean 24-hour plasma insulin concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in mean 24-hour plasma C-peptide concentrations
Prazo: Day -1 (Baseline) up to Day 14
|
The change from baseline in mean 24-hour plasma C-peptide concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in glucose excursions (after breakfast)
Prazo: Day -1 (Baseline) up to Day 14
|
Defined as the difference between the maximum glucose values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in insulin excursions (after breakfast)
Prazo: Day -1 (Baseline) up to Day 14
|
Defined as the difference between the maximum insulin values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in beta cell function
Prazo: Day -1 (Baseline) up to Day 14
|
Beta cell function will be calculated from the glucose, insulin, and C-peptide measurements taken post-breakfast on Day -1 up to Day 14. Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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)
14 de junho de 2007
Conclusão Primária (Real)
5 de dezembro de 2007
Conclusão do estudo (Real)
5 de dezembro de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
20 de dezembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de dezembro de 2012
Primeira postagem (Estimativa)
25 de dezembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de dezembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de dezembro de 2018
Última verificação
1 de dezembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR013765
- 28431754NAP1008 (Outro identificador: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .