临床试验/NCT02817516

NCT02817516终止1 期

A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Doses of TAK-828 in Healthy Subjects

Takeda0 个研究点目标入组 24 人开始时间: 2016年6月30日最近更新: 2019年7月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 24
主要终点: Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

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 evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.

详细描述

The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy non-Japanese and Japanese participants in Parts 1 and 2, respectively.

The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TAK-828 or matching placebo. This assignment will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

Proposed doses:

Part 1: TAK-828 15 mg, 45 mg, 75 mg, 100 mg, and placebo twice daily
Part 2: TAK-828 45 mg, and 100 mg, and placebo twice daily

All participants will be asked to take the solution at the same time each day throughout the study.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Part 1: TAK-828 15 milligram (mg)

Experimental

TAK-828 15 mg, solution (0.2 milligram per milliliter [mg/mL] or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.

干预措施: TAK-828 (Drug)

Part 1: TAK-828 45 mg

Experimental

TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.

干预措施: TAK-828 (Drug)

Part 1: TAK-828 75 mg

Experimental

TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.

干预措施: TAK-828 (Drug)

Part 1: TAK-828 100 mg

Experimental

TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.

干预措施: TAK-828 (Drug)

Part 2: TAK-828 45 mg

Experimental

TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants.

干预措施: TAK-828 (Drug)

Part 2: TAK-828 100 mg

Experimental

TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants.

干预措施: TAK-828 (Drug)

Part 1: Placebo

Placebo Comparator

TAK-828 placebo-matching solution, orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.

干预措施: Placebo (Drug)

Part 2: Placebo

Placebo Comparator

TAK-828 placebo-matching solution, orally, twice daily on Days 1-14 in healthy Japanese participants.

干预措施: Placebo (Drug)