临床试验/NCT02212080

NCT02212080已完成1 期

One-center, Randomized, Placebo-controlled, Double Blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (5-1000 mg, Solution) of BAY1214784 Including the Relative Bioavailability of BAY1214784 Administered as Solution With Two Different Concentrations in 56 Healthy Postmenopausal Women

Bayer0 个研究点目标入组 48 人开始时间: 2014年9月最近更新: 2015年3月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Bayer
入组人数: 48
主要终点: Severity of adverse events (mild, moderate, severe)

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

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.

研究设计

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

入排标准

年龄范围: 45 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Healthy female subjects
•Age 45 to 65 years
•Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
•Postmenopausal state

排除标准

•Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
•Known or suspected malignant or benign tumors
•Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders
•Regular use of medicines

研究组 & 干预措施

BAY1214784

Experimental

Dose 1 to 7 of BAY1214784

干预措施: BAY1214784 (Drug)

Placebo

Placebo Comparator

Placebo Dose 1 to 7 of BAY1214784

干预措施: Placebo (Drug)

结局指标

主要结局

Severity of adverse events (mild, moderate, severe)

时间窗: Up to 2 weeks after dosing

Number of adverse events

时间窗: Up to 2 weeks after dosing

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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