UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009117 |
|---|---|
| Receipt number | 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 18:32:55 |
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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
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
Sponsor or person
Institute
Clinical trial Center,Kitasato University East Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010693
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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