NCT01997879已完成1 期
An Open-label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of AR-13324 Ophthalmic Solution, 0.02% in Healthy Volunteers
Aerie Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年11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
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Assessment
研究概览
简要总结
The purpose of this study is to assess systemic safety and absorption of AR-13324 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female subjects at least 18 years of age.
- •Within 25% of their ideal weights.
- •Medically healthy subjects with clinically insignificant screening results (laboratory profiles, medical histories, ECGs, physical exam) as determined by the Investigator.
- •Non-tobacco/nicotine using subjects (minimum of 3 months non-tobacco/nicotine use prior to first dose).
- •Subjects with two normal (non-diseased) eyes, defined as nonclinically significant in the opinion of the investigator.
- •Intraocular pressure between 14 and 20 mm Hg (inclusive) in each eye at Screening/Qualification.
- •Best-corrected visual acuity (BCVA) in each eye of 20/40 or better.
- •Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.
排除标准
- •Chronic or acute ophthalmic disease including glaucoma, macular degeneration, clinically significant cataract (primary or secondary). Previous cataract surgery.
- •Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
- •Previous glaucoma intraocular surgery or glaucoma laser procedures.
- •Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months (e.g., laser treatment for glaucoma or retina).
- •Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis at (Screening/ Qualification), or a history of herpes simplex keratitis.
- •Ocular medication of any kind within 30 days of Screening/ Qualification
- •Any abnormality preventing reliable applanation tonometry of either eye.
- •Central corneal thickness greater than 600 µm.
- •Cannot demonstrate proper delivery of the eye drop.
- •Blood donations or blood loss, within the past 3 months, that would put the patient at risk with the multiple blood samples required in the present study.
- •Clinically significant abnormalities in laboratory tests at screening.
- •Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
- •Participation in any investigational study within the past 30 days prior to screening.
- •Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
- •Due to status of preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a physician-supervised form of birth control for at least the last two months. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine or serum pregnancy test result at the screening examination and must not intend to become pregnant during the study.
研究组 & 干预措施
AR-13324 Ophthalmic Solution, 0.02%
Experimental
Eyedrop
干预措施: AR-13324 Ophthalmic Solution, 0.02% (Drug)
结局指标
主要结局
Pharmacokinetic Assessment
时间窗: 8 Days
Blood samples obtained to evaluate the systemic exposure (Area Under the Curve (AUC), Maximum Concentration, Time and half-life (Cmax, tmax and t ½)) to ocularly instilled AR-13324 and its metabolites as appropriate.
次要结局
未报告次要终点
研究者
研究点 (1)
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