NCT01064492已完成1 期
A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult 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
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life, as the data permit.
研究概览
简要总结
PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110 administered to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- •Women must be of non childbearing potential.
- •Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
研究组 & 干预措施
ABC, ACB, BAC, BCA, CAB, and CBA
Experimental
干预措施: PF-04620110 (Drug)
结局指标
主要结局
Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life, as the data permit.
时间窗: following each treatment
次要结局
- Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.(before, during, and following treatment)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal InsufficiencyRenal Insufficiency, AcuteRenal Insufficiency, ChronicHealthy SubjectsNCT02808052Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)9
终止
1 期
Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence TrialDiffuse Large B-Cell LymphomaNCT01534949Celltrion1
已完成
1 期
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy ParticipantsHepatic InsufficiencyNCT03341884Genentech, Inc.29
终止
1 期
RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)Malignant Solid TumorMetastatic CancerAdvanced CancerNCT02801097EpicentRx, Inc.28
已完成
1 期
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic ImpairmentChronic Hepatitis CNCT01817985Gilead Sciences33