AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1
研究概览
简要总结
This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
- •HbA1c greater than or equal to 7% and less than or equal to 10.5%
- •Total body weight >50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m^2
排除标准
- •Any condition possibly affecting drug absorption
- •Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
- •History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
- •Any malignancy not considered cured
- •Personal or family history of MTC or MEN2, or participants with suspected MTC
- •Acute pancreatitis or history of chronic pancreatitis
- •Acute gallbladder disease
- •Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
- •Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
- •Clinically relevant ECG abnormalities
- •Positive urine drug test
- •Clinical relevant laboratory tests abnormalities
研究组 & 干预措施
PF-06882961
Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg
干预措施: PF-06882961 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1
时间窗: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1
时间窗: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.
AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
时间窗: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)
AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
时间窗: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)
Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
次要结局
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline up to 14 days after last dose (Day 70))
- Number of Participants With Abnormal Electrocardiogram (ECG)(Baseline up to 14 days after last dose (Day 70))
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)(Baseline up to 35 days after last dose (Day 91))
- Number of Participants With Laboratory Abnormalities(Baseline up to 14 days after last dose (Day 70))