Race Difference Moxifloxacin-induced QT Prolongation Between Healthy Chinese and Caucasian Volunteers

NCT02119091 | Unknown Phase 1

• 1 other identifier: PUTH_CTC_2013_001
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study: Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy Chinese volunteers and Caucasian Volunteers Study Objective:Primary Objective:To compare the difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese group and Caucasian group under the same exposure (Cmax) of Moxifloxacin.Secondary Objectives:1)To compare the difference of ΔΔQTcF, heart rate, PR, RR, QRS and Moxifloxacin plasma concentration between Chinese group and Caucasian group.2)To compare slopes of Moxifloxacin plasma Concentration/QTcF value between healthy Chinese volunteers and Caucasian Volunteers.

Conditions

Cardiac Toxicity

Keywords

QT prolongation; Chinese; Caucasian; Moxifloxacin

Outcome Measures

Primary Outcomes (1)

• ΔΔQTcF

  To compare the difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese group and Caucasian group under the same exposure (Cmax) of Moxifloxacin

  2 months

Study Arms (2)

Moxifloxacin

EXPERIMENTAL

Single oral dose 400 mg

Drug: Moxifloxacin

Placebo

PLACEBO COMPARATOR

Single oral dose

Interventions

Moxifloxacin DRUG

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese subjects, male and female, 18 to 45 years of age, inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.(only for PUTH site) Or, healthy non-Hispanic Caucasian subjects, male and female, 18 to 45 years of age, inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening (only for SCR site).
• At Screening and baseline day, vital signs (systolic and diastolic blood pressure and heart rate rate) will be assessed in the sitting position after the subject has rested for 5 minutes. All of vital signs should be within normal ranges:
• Body temperature (Oral) between 35.0-37.0°C
• mm Hg ≤ systolic blood pressure \<150 mm Hg
• mm Hg≤ diastolic blood pressure \< 90 mm Hg
• beats per minute≤ Heart rate ≤ 90 beats per minute
• Body weight need to be at least 50kg or above, 18Kg/m2≤ Body Mass Index(BMI) ≤31Kg/m2
• Be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent forms prior to any screening procedures.

You may not qualify if:

• Subject has a 12 lead ECG result at Screening or Check in with evidence of any of the following abnormalities after the subject has rested for approximately10 minutes.
• QTcF\>450 ms for males and females
• PR interval \>240 ms or \<110 ms
• Second-degree or third-degree atrioventricular block(AVB)
• Complete left or right bundle branch block or incomplete left bundle branch block
• QRS duration \>120 ms
• Heart rate \<50 beats per minute or \>90 beats per minute
• Pathological Q-waves (defined as Q-wave ≥40 ms)
• Ventricular pre-excitation
• Subject has a history of unexplained syncope, structural heart disease, long QT syndrome, heart failure, myocardial infarction, angina, unexplained cardiac arrhythmia, torsades de points, or ventricular tachycardia. Subjects will also be excluded if there is a family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome.
• Subject has hypokalemia, hypocalcemia, or hypomagnesemia according to lower limits of the reference ranges provided by the clinical laboratory.
• Subject has a history or current evidence of anaphylactic reactions or clinically significant (as determined by the investigator) allergic conditions (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Subject has a hypersensitivity or allergy to moxifloxacin or any drug in the fluoroquinolone class (eg, ciprofloxacin or levofloxacin).
• History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, genetic or psychiatric disorders.
• Current or recent history (\< 30 days prior to Screening) of a clinically significant illness.

Sponsors & Collaborators

• Haiyan Li: lead
• Food and Drug Administration (FDA): collaborator
• Spaulding Clinical Research LLC: collaborator
• BioClinica, Inc.: collaborator
• Peking University: collaborator

Study Sites (2)

Spaulding Clinical Research LLC

West Bend, Wisconsin, 53025, United States

RECRUITING

Peking University Third Hospital Clinical Trial Center

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Long QT Syndrome

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

• Haiyan Li, MD

  Director of Clinical Trial Center,Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingchuan Guo, MD

CONTACT

+86-13811161216; guojingchuan1029@126.com

Lin Xu, BS

CONTACT

8610-82265509; xulin0028@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Trial Center, Peking University Third Hospital, China

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

CN (1); US (1)