Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT01655056
Brief Summary:
The study aims to investigate the effect of YM150 and to compare gender and ethnic differences in healthy Caucasian and Japanese male and female subjects.
Detailed Description:
Each dose group consists of a cohort of 8 Caucasian and 8 Japanese male subjects to be randomized such that 6 subjects of each race receive active treatment and 2 subjects of each race receive matching placebo. The highest tolerated dose is repeated with a cohort of 8 Caucasian and 8 Japanese female subjects, unless emerging safety and PK information justifies higher dose levels or require additional female dose groups.
Each subject is administered a single dose YM150 or placebo on Day 1 followed by multiple doses of YM150 or placebo once daily on Days 3 to 9.
Study:
NCT01655056
Study Brief:
Protocol Section:
NCT01655056