A Double-Blind, Randomized, Placebo-Controlled, 2-Way Cross-Over Study to Evaluate the Effect of Single Dose Canagliflozin on Kinetics of C-Peptide in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change from baseline in C-peptide kinetic parameters
研究概览
简要总结
The purpose of this study is to assess whether treatment with a single oral 300 mg dose of canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a protein released from the pancreas during insulin secretion) in healthy adult volunteers.
详细描述
This is a double-blind (neither the volunteer nor the study doctor/staff will know the identity of the assigned treatments) study to assess the effect of single oral (taken by mouth) dose of canagliflozin on clearance (removal from the body) of C-peptide in healthy adult volunteers. Healthy volunteers will be randomly (by chance) assigned to receive a single oral dose of canagliflozin followed by a single oral dose of placebo (inactive substance) or a single dose of placebo followed by a single dose of canagliflozin with a period of 7-10 days between treatments. Healthy volunteers will also receive intravenous (i.v.) infusion (injection in the vein) of somatostatin for 4 hours and a single dose i.v. injection of synthetic human C-peptide following administration of canagliflozin or placebo during each treatment period. Somatostatin will suppress the normal secretion of C-peptide, a protein that is released from the pancreas during insulin secretion, so that the human C-peptide administered to volunteers can be accurately measured. The total study duration for each volunteer will be approximately 44 days. During the study, blood and urine samples will be drawn (collected) for clinical laboratory evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg
排除标准
- •History of or current clinically significant medical illness as determined by the Investigator
- •History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- •Known allergy or clinically significant adverse reactions to canagliflozin or placebo or any of the excipients of the canagliflozin or placebo formulation
- •Known hypersensitivity of synthetic human C-peptide, somatostatin preparation, or other structurally related peptides
研究组 & 干预措施
Treatment Sequence Group AB
干预措施: Canagliflozin 300 mg (Drug)
Treatment Sequence Group AB
干预措施: Placebo (Drug)
Treatment Sequence Group AB
干预措施: Somatostatin (Drug)
Treatment Sequence Group AB
干预措施: C-peptide (Drug)
Treatment Sequence Group BA
干预措施: Canagliflozin 300 mg (Drug)
Treatment Sequence Group BA
干预措施: Placebo (Drug)
Treatment Sequence Group BA
干预措施: Somatostatin (Drug)
Treatment Sequence Group BA
干预措施: C-peptide (Drug)
结局指标
主要结局
Change from baseline in C-peptide kinetic parameters
时间窗: Before and after study drug administration on Day 1 of Treatment Periods 1 and 2
Parameters are volume of distribution (Vd), clearance (CL) and half life (T1/2)
次要结局
- The number of volunteers who report adverse events(Up to 22 days following Day 1 of Treatment Period 1)
