| CTRI Number |
CTRI/2009/091/000332 [Registered on: 24/06/2009] |
| Last Modified On: |
18/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of moxifloxacin on ECG readings in healthy subjects of Indian origin |
Scientific Title of Study
Modification(s)
|
A randomized, single-dose, single blind, placebo controlled, cross over, validation study of moxifloxacin induced QT/QTc changes in healthy subjects of Indian origin (Indian subcontinent) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| PJMR0032101 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Dimple Shah |
| Designation |
|
| Affiliation |
|
| Address |
Lambda Therapeutic Research Ltd.,
Plot No. 38, Near Silver Oak Club, Sarkhej-Gandhinagar Highway, Gota,
Ahmadabad
GUJARAT
380 061
India |
| Phone |
07940202020 |
| Fax |
|
| Email |
dimpleshah@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Prafulla Bhad |
| Designation |
|
| Affiliation |
Novartis Healthcare Pvt. Ltd. |
| Address |
Novartis Healthcare Pvt. Ltd.,
Building No. 6, Raheja Mindsapce,
Hyderabad
ANDHRA PRADESH
500 081
India |
| Phone |
04067672491 |
| Fax |
|
| Email |
prafulla.bhad@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Prafulla Bhad |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Pvt. Ltd.,
Building No. 6, Raheja Mindsapce,
Hyderabad
ANDHRA PRADESH
500 081
India |
| Phone |
04067672491 |
| Fax |
|
| Email |
prafulla.bhad@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Helathcare Pvt. Ltd., |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Building no. 6, Raheja Mind Space, Madhapur, Hyderabad, 500081, AP, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dimple Shah |
Lambda Therapeutic Research Ltd |
Plot No. 38, Near Silver Oak Club,,Sarkhej-Gandhinagar Highway, Gota, -380061
Ahmadabad
GUJARAT |
07940202020
dimpleshah@lambda-cro.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Study is a pilot study to validate the system for conducting thorough QT/QTc studies in India |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Moxifloxacin |
single dose 400 mg tablets |
| Comparator Agent |
Placebo |
single dose tablets |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and/or female subjects, from 18-55 years of age and in good health.
2. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.5 to 32 kg/m2
3. Female subjects must be: Surgically sterilized at least 6 months prior to study participation or Post-menopausal or must be using two acceptable barrier methods of contraception |
|
| ExclusionCriteria |
| Details |
1. Use of any prescription drug
2. Participation in any clinical investigation
3. QTcF at screening prolonged and past medical history of clinically significant ECG abnormalities
4. Donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
5. Significant illness within the 2 weeks prior to initial dosing
6. History of or presence of risk factors for Torsade de pointes (TdP), including a family history of arrhythmia or sudden death, hypokalemia, hypomagnesia, family history of long QT syndrome
7. History of diabetes mellitus
8. History of hyperthyroidism
Other exclusion critirea from protocol is applicable.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Other |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| QT changes as asseseed by ECG reading at |
Screening*, baseline* (Day -2), ECG baseline (Day -1): equivalent pre-dose (8-10
am) and 1, 1.5, 2, 3, 4, 6, and 12 hours post-dose; Day 1: pre-dose (24 hour post dose for Day -1)
and the post-dose time points of: 1, 1.5, 2, 3, 4, 6,12 and 24 hours and end of study*. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To investigate the change from baseline in the ECG morphology
Mean difference in QTcB and other QTc parameters |
Based on the ECG recorded as per primary outcome |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
30/05/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
30/05/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="1"
Days="16" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized, single-dose, single blind, placebo controlled, cross over study in healthy subjects. All eligible subjects will participate in a screening period (up to 21 days), two baseline visit, two ECG baseline visits (Day -1) and two single dose treatment periods with a wash out period of 7 days between dosing. An end-of-study evaluation will be conducted 5-7 days after the last dose. The central reader of ECGs will be blinded with regard to time, subject, treatment and period identification. |