Tacoma, Washington, 98418, United States
NCT Number: NCT00850746
A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults
This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
YM443
DrugOral
Other names: Z-338, acotiamide hydrochloride
Placebo
DrugOral
moxifloxacin
DrugOral
Other names: Avelox
Primary outcomes
-
Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo
Time frame: Following four days of dosing
Secondary outcomes
-
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
-
The pharmacokinetics of YM443 in these subjects
Time frame: Day 5
-
The safety and tolerability of YM443
Time frame: Following four days of dosing
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Registry information
Official study 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
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Feb 25, 2009
- Registry last updated
- Mar 24, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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