NCT02300350已完成1 期
A Phase 1, Single-center, Open-label, Two-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Digoxin (Lanoxin®), a Sensitive P-glycoprotein (P-gp) Substrate, in Healthy Male and Female Subjects
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
- AUC
研究概览
简要总结
This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult subjects ≥18 to ≤55 years of age
- •Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
- •Body mass index (BMI) ≥18 and ≤32 kg/sq m
- •Willing and able to provide written informed consent
排除标准
- •Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
- •History of clinically significant arrhythmias
- •History of cardiac arrhythmias or palpitations associated with presyncope, syncope, or a family history of sudden cardiac death
- •Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study
- •Receipt of any investigational agent or study drug within 30 days prior to Screening
- •Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening
- •Prior exposure to LX4211
- •Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
- •History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or digoxin
- •Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or digoxin
- •History of any major surgery within 6 months or anticipated surgery prior to Day 1
- •History of any clinically significant hypoglycemia or hyperglycemia
- •History of renal disease, or significantly abnormal kidney function test at Screening
- •History of hepatic disease, or significantly abnormal liver function tests at Screening
- •History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
- •History of any active infection within 14 days prior to Day 1
- •History of alcohol or substance abuse within 2 years prior to Screening
- •Positive hepatitis panel
- •Donation or loss of >500 mL of blood or blood product within 3 months prior to Screening
- •Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test
- •Positive urine glucose at Screening
- •Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13
- •Inability or difficulty swallowing whole tablets
- •Unable or unwilling to cooperate with the Investigator for any reason
研究组 & 干预措施
Treatment B
Experimental
400 mg oral LX4211 qd administration
干预措施: Treatment B LX4211 (Drug)
Treatment A
Experimental
0.5 mg single-dose oral digoxin administration
干预措施: Treatment A digoxin (Drug)
Treatment C
Experimental
0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration
干预措施: Treatment C Digoxin + 400 mg LX4211 administered concomitantly (Drug)
结局指标
主要结局
AUC
时间窗: Day 1-Day 7, Day 20-26
次要结局
- Adverse Events(Day 1-Day 26)
研究者
研究点 (1)
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