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

NCT00850746 | Completed Phase 1

• 1 other identifier: 443-CL-048
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Dyspepsia

Keywords

QT interval; Cardiac Repolarization; Cardiac Conduction; Healthy Subjects; YM443 (Z-338, acotiamide hydrochloride); Evaluation of QT Interval

Outcome Measures

Primary Outcomes (1)

• Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo

  Following four days of dosing

Secondary Outcomes (3)

• The mean change of the QTcI (Individual correction) and QTcB (Bazett's correction) between each active treatment and placebo.

  Following four days of dosing

• The pharmacokinetics of YM443 in these subjects

  Day 5

• The safety and tolerability of YM443

  Following four days of dosing

Study Arms (4)

A. Placebo

PLACEBO COMPARATOR

Drug: Placebo

B. Ym443 Lower Dose

EXPERIMENTAL

Drug: YM443

C. YM443 Higher Dose

EXPERIMENTAL

Drug: YM443

D. Moxiflocxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Interventions

YM443 DRUG

Oral

Also known as: Z-338, acotiamide hydrochloride

B. Ym443 Lower Dose; C. YM443 Higher Dose

Placebo DRUG

Oral

A. Placebo

Moxifloxacin DRUG

Oral

Also known as: Avelox

D. Moxiflocxacin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Male or non pregnant, non lactating female
• Weighing at least 45 kg
• Body Mass Index (BMI) between 18 and 32 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Interventions

Z 338; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

US (1)