NCT01188304已完成1 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of 150 µg Aleglitazar Once Daily in Healthy Subjects Treated With 325 mg Aspirin Once Daily on Renal Function, Renin-angiotensin System and Platelet Aggregation
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
- 44
- 主要终点
- To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate
研究概览
简要总结
This randomized, double-blind, placebo-controlled, parallel group study will investigate the safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with aspirin. The anticipated time on study drug is 5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, aged 40 to 65 years inclusive
- •Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive
- •Females of child-bearing potential must be willing to use two acceptable methods of contraception during the study and at least 3 months before start of the study
- •Non-smoker or currently smoking less than 5 cigarettes (or equivalent amount of other tobacco products) per day and is willing and able to stop smoking during the period in study center
- •Volunteer drinks no more than 3 cups of coffee, tea or soft drinks per day and is willing and able to stop drinking coffee, tea and soft drinks during the period in study center
排除标准
- •Any clinically relevant abnormal laboratory test results at screening
- •Volunteer has taken any prescribed, herbal or over-the-counter medication within 2 weeks prior to first dosing
- •A history of any clinical significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, bronchopulmonary or neurological conditions or lipid disorders
- •A positive test for human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B or hepatitis C
- •History of intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, history of gastric or duodenal ulceration, personal or family history of abnormal clotting or bleeding
研究组 & 干预措施
1
Experimental
干预措施: aspirin (Drug)
1
Experimental
干预措施: aleglitazar (Drug)
2
Placebo Comparator
干预措施: aspirin (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate
时间窗: 13 weeks
次要结局
- To investigate safety and tolerability of aleglitazar(13 weeks)
- To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate(13 weeks)
- To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone(13 weeks)
- To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin(13 weeks)
- To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances(13 weeks)
- To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2(13 weeks)
研究者
相似试验
已完成
1 期
A Study of Aleglitazar in Combination With Ibuprofen in Healthy VolunteersHealthy VolunteerNCT01188317Hoffmann-La Roche44
已完成
2 期
MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant TherapyMajor Depressive DisorderNCT01437657Hoffmann-La Roche319
已完成
2 期
A Study of RO4917523 in Pediatric Patients With Fragile X SyndromeFragile X SyndromeNCT01750957Hoffmann-La Roche47
已完成
2 期
A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) InfectionCervical Intraepithelial NeoplasiaNCT01022346Hoffmann-La Roche206
已完成
3 期
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in KoreanAcute MigraineNCT04218162IlDong Pharmaceutical Co Ltd294