A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults
NCT ID: NCT00850746
Last Updated: 2014-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2009-02-28
2009-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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A. Placebo
Placebo
Oral
B. Ym443 Lower Dose
YM443
Oral
C. YM443 Higher Dose
YM443
Oral
D. Moxiflocxacin
Moxifloxacin
Oral
Interventions
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YM443
Oral
Placebo
Oral
Moxifloxacin
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weighing at least 45 kg
* Body Mass Index (BMI) between 18 and 32 kg/m2
Exclusion Criteria
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Tacoma, Washington, United States
Countries
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Other Identifiers
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443-CL-048
Identifier Type: -
Identifier Source: org_study_id
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