Clinical trial NCT00850746: A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Functional Dyspepsia
Keywords: QT interval
Cardiac Repolarization
Cardiac Conduction
Healthy Subjects
YM443 (Z-338, acotiamide hydrochloride)
Evaluation of QT Interval
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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 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

Primary outcomes:
measure: Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo
timeFrame: Following four days of dosing
Secondary outcomes:
measure: The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo.
timeFrame: Following four days of dosing
measure: The pharmacokinetics of YM443 in these subjects
timeFrame: Day 5
measure: The safety and tolerability of YM443
timeFrame: Following four days of dosing
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References: