A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 23, 2009

Last Updated Date

April 14, 2009

Start Date ^†

February 2009

Current Primary Outcome Measures ^†

Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo [ Time Frame: Following four days of dosing ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00850746 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo. [ Time Frame: Following four days of dosing ] [ Designated as safety issue: No ]
The pharmacokinetics of YM443 in these subjects [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
The safety and tolerability of YM443 [ Time Frame: Following four days of dosing ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults

Official Title ^†

A Phase 1, Randomized, Double-Blind, Placebo- and Active- Controlled, Crossover Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Male and Female Adult Subjects

Brief Summary

This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults.

Detailed Description

Each subject participates in all four treatment periods separated by washout periods.

In order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study

Condition ^†

Cardiac Repolarization

Intervention ^†

Drug: YM443
Drug: Placebo
Drug: Moxifloxacin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Healthy Male or non pregnant, non lactating female
Weighing at least 45 kg
Body Mass Index (BMI) between 18 and 32 kg/m2

Exclusion Criteria:

The subject has evidence of any cardiac conduction abnormalities
The subject has a previous history of any medical or psychiatric condition that would preclude participation in the study
The subject has participated in another clinical trial in the last 30 days
The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 48 hours prior to the administration of the first dose of YM443 on Day 1 of Period 1 and throughout the duration of the study
The subject has used tobacco-containing products and nicotine or nicotine-containing products within six months prior to Screening
The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week or has a history of substance abuse, drug addiction, or alcoholism within 2 years prior to Screening
The subject has donated any whole blood or cellular blood component or has undergone significant loss of blood or has received transfusion of any blood or blood products within 56 days of Day -1 of Period 1 or has donated plasma within 7 days of Day -1 of Period 1

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00850746

Responsible Party

Sr Manager Clincal Trials Registry, Astellas Pharma Global Development

Secondary IDs ^††

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Director:

Use Central Contact

Astellas Pharma Global Development

Information Provided By

Astellas Pharma Inc

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.