The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

NCT ID: NCT01876316

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-01-31

Brief Summary

The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

Detailed Description

The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Moxifloxacin

single oral administration of 400mg of moxifloxacin

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

single oral administration of 400mg of moxifloxacin

Placebo

single oral administration of 400mg of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single oral administration of 400mg of placebo

Interventions

Moxifloxacin

single oral administration of 400mg of moxifloxacin

Intervention Type: DRUG

Placebo

single oral administration of 400mg of placebo

Intervention Type: DRUG

Other Intervention Names

Avelox; Lactose

Eligibility Criteria

Inclusion Criteria

• 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.

2) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ [height (m)]2.

Exclusion Criteria

• 1) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.

2) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.

• Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
• PR ≥ 210 msec
• QRS ≥ 120 msec
• QT ≥ 500 msec
• QTcF: male ≥ 450 msec, female ≥470msec
• Iincomplete right bundle branch block
• Marked Sinus Arrhythmia
• Wondering pacemaker
• Atrial rhythm

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inje University

OTHER

Sponsor Role: lead

Responsible Party

Jae-Gook Shin

Department of Pharmacology and Pharmacogenomics Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae-Gook Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

References

Choi HK, Jung JA, Fujita T, Amano H, Ghim JL, Lee DH, Tabata K, Song ID, Maeda M, Kumagai Y, Mendzelevski B, Shin JG. Population Pharmacokinetic-Pharmacodynamic Analysis to Compare the Effect of Moxifloxacin on QT Interval Prolongation Between Healthy Korean and Japanese Subjects. Clin Ther. 2016 Dec;38(12):2610-2621. doi: 10.1016/j.clinthera.2016.10.011.

Reference Type: DERIVED

PMID: 28003052 (View on PubMed)

Other Identifiers

12-166

Identifier Type: -

Identifier Source: org_study_id