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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850746
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: YM443 Drug: Placebo Drug: Moxifloxacin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : February 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: A. Placebo Drug: Placebo
Oral

Experimental: B. Ym443 Lower Dose Drug: YM443
Oral
Other Names:
  • Z-338
  • acotiamide hydrochloride

Experimental: C. YM443 Higher Dose Drug: YM443
Oral
Other Names:
  • Z-338
  • acotiamide hydrochloride

Active Comparator: D. Moxiflocxacin Drug: Moxifloxacin
Oral
Other Name: Avelox




Primary Outcome Measures :
  1. Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo [ Time Frame: Following four days of dosing ]

Secondary Outcome Measures :
  1. 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 ]
  2. The pharmacokinetics of YM443 in these subjects [ Time Frame: Day 5 ]
  3. The safety and tolerability of YM443 [ Time Frame: Following four days of dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850746


Locations
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United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Use Central Contact Astellas Pharma Global Development

Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00850746    
Other Study ID Numbers: 443-CL-048
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014
Keywords provided by Astellas Pharma Inc:
QT interval
Cardiac Repolarization
Cardiac Conduction
Healthy Subjects
YM443 (Z-338, acotiamide hydrochloride)
Evaluation of QT Interval
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Moxifloxacin
Z 338
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Cholinergic Agents
Neurotransmitter Agents
Gastrointestinal Agents