A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of Cvx-096 In Type 2 Diabetic Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
研究概览
简要总结
The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
- •Hb A1c between 7-10%.
- •Fasting C-peptide >0.4 nmol/L.
排除标准
- •History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
- •Patients with pancreatitis or considered a high risk for pancreatitis.
- •History of contraindications to metformin therapy.
- •Previous treatment with an approved or investigational GLP 1 mimetic.
结局指标
主要结局
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
时间窗: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8
时间窗: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1
时间窗: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22
时间窗: pre-dose, 1 and 6 hours post-dose on Day 22
Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1
时间窗: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8
时间窗: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22
时间窗: pre-dose, 1 and 6 hours post-dose on Day 22
次要结局
- Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22(pre-dose, 1 and 6 hours post-dose on Day 22)
- Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1(pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1)
- Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1(pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1)
- Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1(pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1)
- Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8(pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8)
- Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1(pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1)