NCT01514812

A Study to Investigate the Effect of YM150 on the Plasma Concentration of Digoxin in Healthy Subjects

A Double Blind, Randomized, Two Period Crossover Study To Determine The Effect of Multiple Doses of 120 MG Modified Release Formulation of YM150 on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in healthy subjects.

Detailed description

The study will be of a double blind, randomized, two period crossover design. Two treatments, digoxin in combination with YM150, and digoxin in combination with placebo, will be evaluated. Each subject will receive both treatments in random order. Placebo will be used to maintain the blind. Males and females will be equally divided over the treatment orders. Subjects will be dosed with digoxin and either YM150 or placebo for 8 days to reach steady state. In the second period the subjects will receive digoxin and the alternate treatment. There will be a washout period of at least 10 days between the consecutive treatments. In both study periods the subjects will be admitted the day prior to study drug administration (Day 0). The subjects will be discharged on Day 10. Approximately one week after the last discharge, the subjects will return to the unit for a post study visit.

Conditions

• Healthy
• Pharmacokinetic of Digoxin

Interventions

Type	Name	Description
DRUG	YM150	oral - modified release formulation of YM150
DRUG	placebo	oral
DRUG	digoxin	oral

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2012-01-23
• Last updated: 2012-01-24

Locations

1 site across 1 country: France