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

Functional Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850746
• Other study ID #: 443-CL-048
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2009
• Last updated: March 21, 2014
• Start date: February 2009
• Est. completion date: April 2009

Study information

• Verified date: March 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Functional Dyspepsia

Intervention

Drug:
• YM443
Oral
• Placebo
Oral
• Moxifloxacin
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo		Following four days of dosing	No
Secondary	The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo.		Following four days of dosing	No
Secondary	The pharmacokinetics of YM443 in these subjects		Day 5	No
Secondary	The safety and tolerability of YM443		Following four days of dosing	No

External Links

•   Link to Results on JAPIC