A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
研究概览
简要总结
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)
排除标准
- •Patients with cardiovascular event within 6 months of screening
- •Patients with diabetic complications
- •Female subjects who are pregnant or planning to become pregnant
- •Subjects with unstable medical conditions (eg, hypertension)
研究组 & 干预措施
PF-04937319 IR MST
Reference formulation
干预措施: PF-04937319 IR MST (Drug)
PF-04937319 MR 1
Test MR #1
干预措施: PF-04937319 MR 1 (Drug)
PF-04937319 MR 2
Test MR #2
干预措施: PF-04937319 MR 2 (Drug)
PF-04937319 MR 3
Test MR #3
干预措施: PF-04937319 MR 3 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
时间窗: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
时间窗: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.
次要结局
- Maximum Observed PF-04937319 Plasma Concentration (Cmax)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)
- PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)
- PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)
- Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline up to 28 days after last study drug administration in Period 4)
- PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)
- Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)
- Terminal Elimination Half-Life (t1/2)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)
- Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)(0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose)