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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009117
Receipt No. R000010693
Scientific Title A Randomized, double-blind, placebo-controlled, two-way crossover trial to compare Moxifloxacin induced QT interval prolongation in Japanese and Korean healthy subjects
Date of disclosure of the study information 2012/10/15
Last modified on 2012/10/15

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Basic information
Public title A Randomized, double-blind, placebo-controlled, two-way crossover trial to compare Moxifloxacin induced QT interval prolongation in Japanese and Korean healthy subjects
Acronym Moxifloxacin induced QT interval prolongation in Japanese and Korean healthy subjects
Scientific Title A Randomized, double-blind, placebo-controlled, two-way crossover trial to compare Moxifloxacin induced QT interval prolongation in Japanese and Korean healthy subjects
Scientific Title:Acronym Moxifloxacin induced QT interval prolongation in Japanese and Korean healthy subjects
Region
Japan Asia(except Japan)

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to explore the ethnic difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects. For this, the pharmacokinetics and pharmacodynamics of a single oral dose of Moxifloxacin 400mg will be compared between Japanese and Korean healthy male and female subjects
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QT prolongation of Moxifloxacin
Key secondary outcomes safety

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Moxifloxacin
Interventions/Control_2 Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria 1. Signed Written Informed Consent
1) The signed informed consent form
2. Target Population
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.
3. Age, Sex, and Reproductive Status
1) Male and female, ages 20 to 35 years inclusive.
2) Female must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product.
3) Female must not be breastfeeding.
Key exclusion criteria 1.Medical History and Concurrent Diseases
1)Any significant acute or chronic medical illness.
2)Subject with clinically significant hepatic disorder
3)History of epilepsy
4)History of hypoglycemia
5)Any gastrointestinal surgery that could impact upon the absorption of study drug.
6)Donation of blood
Less than 200ml within 30days prior to study drug administration
more than 200ml Within 90 days prior to study drug administration
7)Smoking more than 10 cigarettes per day.
8)Any major surgery within 4 weeks prior to study drug administration.
9)Received any investigational drug within 120 days prior to study drug administration
10)Any other sound medical, psychiatric and/or social reason as determined by the investigators.
2.Physical and Laboratory Test Findings
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.
-HR<45 bpm or HR>100 bpm
-PR=<210 msec
-QRS=<120 msec
-QT=<500 msec
-QTcF: male=<450 msec, female=<470msec
-IRBBB
-Marked Sinus Arrhythmia
-Wondering pacemaker
-Atrial rhythm
3)Positive urine screen for drugs of abuse.
4)Positive alcohol breath test
5)Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV-1, -2 antibody or serological reaction of syphilis.
3.Allergies and Adverse Drug Reaction
1)History of severe allergic disease.
2)History of allergy or intolerance moxifloxacin or any member of the quinolone drug class.
3)History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
4.Other Exclusion Criteria
and so on
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Kumagai
Organization Kitasato University East Hospital
Division name Clinical trial Center
Zip code
Address 2-1-1 Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitasato University East Hospital
Division name Clinical trial Center
Zip code
Address 042-748-9111
TEL
Homepage URL
Email

Sponsor
Institute Clinical trial Center,Kitasato University East Hospital
Institute
Department

Funding Source
Organization Clinical trial Center,Kitasato University East Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Inje University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 15 Day
Last modified on
2012 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010693

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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