NCT01546597已完成1 期
A Phase 1, Open-Label, Single Cohort, Four-period Sequential Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of metformin
研究概览
简要总结
The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).
详细描述
The primary objective of this study is as follows:
• To evaluate the effect of steady-state ranolazine on the steady state PK of metformin in subjects with T2DM.
The secondary objectives of this study are as follows:
- To examine the safety and tolerability of metformin when co administered with ranolazine at steady-state in subjects with T2DM.
- To determine the steady-state PK of ranolazine in subjects with T2DM receiving metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 30 to 65 years old, inclusive
- •Documented history of T2DM
- •HbA1c = 6.5%-10%, inclusive
- •Fasting serum glucose ≤ 270 mg/dL at Screening
- •Fasting C-peptide ≥ 1 ng/mL at Screening
- •Stable metformin monotherapy (metformin 1000 to 2000 mg total daily dose for at least 4 weeks prior to Screening)
- •Body mass index (BMI) = 25 to 40 kg/m2, inclusive, at Screening
- •Creatinine Clearance > 80 mL/min at Screening
- •Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug
排除标准
- •Type 1 Diabetes Mellitus (T1DM)
- •Use of insulin therapy < 3 months prior to Screening
- •History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis
- •Clinically significant complications of diabetes
- •History of hypoglycemia
- •Any non-insulin antidiabetic therapy (other than metformin) < 2 months prior to Screening
- •Any clinically significant cardiovascular event < 2 months prior to Screening
- •Clinically significant, inadequately controlled, or unstable hypertension
- •Hospitalization < 2 months prior to Screening or major surgery < 3 months prior to Screening
- •History of gastrointestinal disease or surgery that could impact drug absorption
- •History of substance of alcohol or substance abuse
- •Positive urine drug screen for drugs of abuse
- •Positive alcohol breath test
- •Any other clinically significant existing medical or psychiatric condition or one requiring further evaluation
- •Treatment with selected medications
- •Hemoglobin < 12 g/dL for males; or < 11 g/dL for females at Screening
- •Active thyroid disease (hypo- or hyperthyroidism)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5x upper limits of normal
- •QTc interval > 500 msec at Screening
- •Females who are pregnant or are breastfeeding
研究组 & 干预措施
Metformin, Ranolazine
Experimental
Single cohort, 4-period study:
- Period 1, metformin 500 mg bid on Days 1-5
- Period 2, metformin 850 mg bid on Days 6-10
- Period 3, metformin 500 mg bid + ranolazine 1000 mg bid on Days 11-15
- Period 4, metformin 850 mg bid + ranolazine 1000 mg bid on Days 16-20
干预措施: Metformin (Drug)
Metformin, Ranolazine
Experimental
Single cohort, 4-period study:
- Period 1, metformin 500 mg bid on Days 1-5
- Period 2, metformin 850 mg bid on Days 6-10
- Period 3, metformin 500 mg bid + ranolazine 1000 mg bid on Days 11-15
- Period 4, metformin 850 mg bid + ranolazine 1000 mg bid on Days 16-20
干预措施: Ranolazine (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of metformin
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
Time to reach maximum observed plasma concentration (Cmax) of metformin
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of metformin
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5, 10, 15 and 20
次要结局
- Number of participants with adverse events(participants will be followed upon signing informed consent until the follow-up phone call, an expected average of 7 weeks)
- Maximum observed plasma concentration (Cmax) of ranolazine and metabolites(0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20)
- Time to reach maximum observed plasma concentration (Cmax) of ranolazine and metabolites(0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20)
- Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of ranolazine and metabolites(0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 15 and 20)
研究者
研究点 (1)
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