A Phase 1, Single-Part, 6-Period, Sequential, Non-Randomized, Open-Label Study Designed to Evaluate the Pharmacokinetic Profile of Tolcapone Following Administration of Modified Release Prototype Formulations and an Experimental Divided Dose Regimen in Healthy Subjects

Corino Therapeutics, Inc.1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2018年6月25日最近更新: 2019年1月31日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Corino Therapeutics, Inc.
入组人数: 12
试验地点: 1
主要终点: Pharmacokinetic Assessment: Time to maximum concentration (Tmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy males or non-pregnant, non-lactating healthy females
•Age 18 to 65 years of age at the time of signing informed consent
•Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
•Must be willing and able to communicate and participate in the whole study
•Must provide written informed consent
•Must agree to use an adequate method of contraception

排除标准

•Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose.
•Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
•Subjects who have previously been enrolled in this study.
•History of any drug or alcohol abuse in the past 2 years.
•Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
•Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
•Females of childbearing potential who are pregnant or lactating
•Subjects who do not have suitable veins for multiple venepunctures / cannulation as assessed by the investigator at screening
•Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
•Hemoglobin below the lower limit of normal
•ALT or AST outside the normal reference range at screening or admission.
•Confirmed positive drugs of abuse test result
•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
•History of clinically significant cardiovascular, neurological, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
•Subjects with a history of cholecystectomy or gall stones
•Serious adverse reaction or serious hypersensitivity to any drug, the formulation excipients, or lactose intolerance
•Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
•Donation or loss of greater than 400 mL of blood within the previous 3 months
•Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration.
•Contraindication for Tasmar®
•Failure to satisfy the investigator of fitness to participate for any other reason
•NOTE: Other inclusion/exclusion criteria may apply, per protocol

研究组 & 干预措施

Modified Release Prototypes of Tolcapone

Experimental

干预措施: Tolcapone (Drug)

Modified Release Prototypes of Tolcapone

Experimental

干预措施: Tolcapone Modified Release Prototype (Drug)

Modified Release Prototypes of Tolcapone

Experimental

干预措施: Tolcapone Divided Dose (Drug)