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临床试验/NCT02432313
NCT02432313已完成1 期

3-Part Study With 2 6-Period Single Dose Parts (Pt 1, Pt 2 Optional) Followed by a 1-Period Multiple Dose Part (Pt 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine PK

Rock Creek Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2015年1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
入组人数
37
试验地点
1
主要终点
PK measures of blood anatabine

研究概览

简要总结

Parts 1 and 2:

Subjects take 1 dose of various formulations of the study product, and provide samples for pharmacokinetic (PK) analysis after each, with at least 7 days between doses.

Part 3:

Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and provides samples for PK analysis.

详细描述

Parts 1 and 2:

Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight and receive the study product in the morning of Day 1 in a non-randomized manner. Subjects will remain onsite until 24 h post-dose and will return to the clinical unit at 36 and 48 h post-dose to provide a sample for PK analysis.

There will be at least a 7-day washout between regimens. Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.

Part 3:

Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight (for Day 1 and Day 7) and receive the study product or placebo on a once, twice, or three times a day regimen in a randomized, double-blind manner. Subjects will remain onsite until 24 h after the final dose (Day 7), leaving the clinic on the morning of Day 8 and returning at 36 and 48 h post last-dose to provide a sample for PK analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • negative for urinary cotinine
  • normal test values for liver function
  • provide informed consent

排除标准

  • clinically significant abnormal biochemistry, hematology, or urinalysis, as judged by the investigator

研究组 & 干预措施

Modified Release Formulation x (MRx)

Experimental

Various formulations of Modified Release anatabine citrate tablets

干预措施: Modified Release Formulation x (MRx) (Drug)

结局指标

主要结局

PK measures of blood anatabine

时间窗: 0-2 hrs (every 15 min); 2-6 hrs (every 30 min); 6-12 hr (every 60 min); at 18, 24, 36, and 48 hr

次要结局

  • reported adverse events or serious adverse events(immediately post-dose to 5-days post-dose)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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