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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00850746

Purpose

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

Condition	Intervention	Phase
Cardiac Repolarization	Drug: YM443 Drug: Placebo Drug: Moxifloxacin	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study
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

Resource links provided by NLM:

Drug Information available for: Moxifloxacin Acotiamide Moxifloxacin hydrochloride Acotiamide hydrochloride

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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 ]

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 ]

Enrollment:	80
Study Start Date:	February 2009
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A. Placebo: Placebo Comparator	Drug: Placebo Oral
B. Ym443 Lower Dose: Experimental	Drug: YM443 Oral
C. YM443 Higher Dose: Experimental	Drug: YM443 Oral
D. Moxiflocxacin: Active Comparator	Drug: Moxifloxacin Oral

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850746

Locations

United States, Washington

Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Global Development ( Sr Manager Clincal Trials Registry )
Study ID Numbers:	443-CL-048
Study First Received:	February 23, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00850746 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

QT interval
Cardiac Repolarization
Cardiac Conduction

Healthy Subjects
YM443 (Z-338, acotiamide hydrochloride)
Evaluation of QT Interval

Study placed in the following topic categories:

Anti-Infective Agents
Moxifloxacin
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Moxifloxacin
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009