NCT01060475已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of LIM-0705 Given With or Without Tacrolimus in Healthy Male Subjects
Limerick BioPharma2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2010年2月最近更新:
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
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
研究概览
简要总结
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male age 18-50
- •Patient in good health as deemed by pre-study exam and history
- •BMI 20-30 kg/sq. meter
- •Absence of tremors
- •Must be willing to remain in confinement for 17 days/16 nights
- •Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm
- •Subject must be non-smoker or willing to abstain from smoking day -4 through day
- •Subject must abstain from alcohol, grapefruit,and caffeine-containing beverages starting Day -2 through Day
- •Subjects must use double-barrier contraception through course of study + 90 days following study
排除标准
- •Allergy to red wine or onions
- •Strict vegetarians
- •Use of any non-study medication
- •Use of chemotherapy within 5 years prior to Screening visit
- •Use of any dietary aids
- •Difficultly swallowing oral medications
- •cognitive or psychiatric disorders
研究组 & 干预措施
A
Experimental
Low dose LIM-0705 and tacrolimus.
干预措施: LIM-0705 and tacrolimus (Drug)
B
Experimental
High dose LIM-0705 and tacrolimus.
干预措施: LIM-0705 and tacrolimus (Drug)
C
Experimental
Placebo LIM-0705 and tacrolimus.
干预措施: Placebo LIM-0705 and tacrolimus (Drug)
D
Experimental
High dose LIM-0705 and placebo tacrolimus.
干预措施: Drug LIM-0705 and placebo tacrolimus (Drug)
结局指标
主要结局
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
时间窗: 14 days
次要结局
- Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).(14 days)
研究者
研究点 (2)
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