UMIN-CTR Clinical Trial

Public title

The effects of a single oral therapeutic dose of Moxifloxacin on the QT/QTc interval and pharmacokinetics of healthy Japanese male volunteers.
- multicenter, digital 12-lead Holter ECG trial-

Acronym

The effects of a single oral therapeutic dose of Moxifloxacin on the QT/QTc interval and pharmacokinetics of healthy Japanese male volunteers.
- multicenter, digital 12-lead Holter ECG trial-

Scientific Title

The effects of a single oral therapeutic dose of Moxifloxacin on the QT/QTc interval and pharmacokinetics of healthy Japanese male volunteers.
- multicenter, digital 12-lead Holter ECG trial-

Scientific Title:Acronym

The effects of a single oral therapeutic dose of Moxifloxacin on the QT/QTc interval and pharmacokinetics of healthy Japanese male volunteers.
- multicenter, digital 12-lead Holter ECG trial-

Region

Japan

Condition

Healthy male

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effects of a single oral therapeutic dose of Moxifloxacin on the QT/QTc intervals, which are recorded using 12-lead Holter EGC, and pharmacokinetics of healthy Japanese male volunteers at multiple sites.

Basic objectives2

PK,PD

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

QT/QTc interval and pharmacokinetics after single dose of Moxifloxacin

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To administer single oral dose of Moxifloxacin 400mg

Interventions/Control_2

To administer single oral dose of 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

Age-lower limit

20

years-old

<=

Age-upper limit

40

years-old

>=

Gender

Male

Key inclusion criteria

1, Healthy Japanese male subjects who provide signed written informed consent.
2, Subjects between 20 and 40 (inclusive) year of age at the time of consent.
3, Subjects with BMI <=18.5 and >25.0 at the time of screening.
4, Subjects judged as adequate for this study by study physician.

Key exclusion criteria

1, Subjects with present illness which requires treatment.
2, Subjects with past medical history which was considered not adequate for this study.
3, Subjects with past history of drug allergy (includes allergy to Moxifloxacin).
4, Subjects with abnormal finding on 12-lead ECG which might interfere with the completion of this study at screening, admission of site at period 1, and pre-dose.
5, Subjects with family history of LQT syndrome.
6, Subjects who took medication/supplement which is known to affect QT/QTc interval 3 months prior to administration of period 1.
7, Subjects who took prescribed medicine and/or OTC drug 1 week prior to administration of period 1.
8. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to administration of period 1.
9, Subjects who participated in a clinical trial and was administered study drug.
10, Subjects with history of alcohol and/or drug abuse.
11, Subjects who was judged not appropriate for this study by study physician.

Target sample size

64

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Kaji

Organization

Medical Co. LTA Clinical Pharmacology Center

Division name

Clinical Pharmacology Department

Zip code

Address

2-13-16 Jigyo Chuo-ku, Fukuoka

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Medical Co. LTA Clinical Pharmacology Center

Division name

Clinical Pharmacology Department

Zip code

Address

2-13-16 Jigyo Chuo-ku, Fukuoka

TEL

Homepage URL

Email

Institute

Medical Co. LTA Clinical Pharmacology Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Ina Research Inc.
Cardiocore Lab, Inc.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人相生会　九州臨床薬理クリニック（福岡県）
医療法人相生会　博多クリニック（福岡県）
医療法人相生会　墨田病院（東京都）
医療法人相生会　にしくまもと病院（熊本県）

Date of disclosure of the study information

2011

Year

07

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

2011

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

07

Month

05

Day

Last modified on

2011

Year

09

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007008