NCT01655056

A Study to Evaluate the Safety and Tolerability of YM150 in Healthy Caucasian and Japanese Male and Female Subjects, and to Assess the Effect That Gender May Have on Its Actions in the Body

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YM150 in Healthy Caucasian and Japanese Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics
• Pharmacodynamics
• Healthy Subjects
• Caucasian
• Japanese

Interventions

Type	Name	Description
DRUG	YM150	oral
DRUG	Placebo	oral

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2012-08-01
• Last updated: 2013-06-26

Locations

1 site across 1 country: Germany