| CTRI Number |
CTRI/2009/091/000582 [Registered on: 18/09/2009] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to check activity of certain enzymes in the body after taking a drug called AEB071 |
|
Scientific Title of Study
|
An open-label, single-sequence pharmacokinetic study in
healthy subjects to assess the potential of AEB071 to
inhibit and induce CYP1A2 using caffeine as a probe
substrate |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CAEB071A2120 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shobha Rajgopal |
| Designation |
|
| Affiliation |
|
| Address |
Lotus labs Pvt Ltd., Lotus House No.07, Jasma Bhavan
Miller's Tank bed area, opposite gurunanak bhavan, vasanthnagar
Bangalore
KARNATAKA
560052
India |
| Phone |
0984501298 |
| Fax |
08022370911 |
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinu Jose |
| Designation |
|
| Affiliation |
Novartis Healthcare Pvt. Ltd. |
| Address |
3W-146, Raheja Mindspace
Hitech city
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
04067672946 |
| Fax |
04067671300 |
| Email |
vinu.jose@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vinu Jose |
| Designation |
|
| Affiliation |
|
| Address |
3W-146, Raheja Mindspace
Hitech city
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
04067672946 |
| Fax |
04067671300 |
| Email |
vinu.jose@novartis.com |
|
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Source of Monetary or Material Support
|
| Novartis Healthcare Pvt. Ltd. |
|
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Primary Sponsor
|
| Name |
Novartis Healthcare Pvt. Ltd. |
| Address |
|
| Type of Sponsor |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bharathi Rao |
Lotus Labs Pvt Ltd |
St. John's National Academy of Health Sciences,141/2, John nagar-560034
Bangalore
KARNATAKA |
08022370911
bharathi_rao@lotuslabs.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC consultants |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Prevention of Transplant rejection, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AEB071 |
300mg orally twice-daily for 10 days |
| Intervention |
Caffiene |
100mg Orally |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Non-smokers
Age: 18 to 45 years
Good health conditions
Post-menopausal or surgically sterilised females
|
|
| ExclusionCriteria |
| Details |
Use of any prescription drugs within 4weeks prior to dosing.
Donation or loss of 400ml or more blood.
Significant illness subjects.
No significant ECG abnormalities.
History of immunodefficiency disease. |
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| to quantify the change from baseline in caffeine pharmacokinetics when co-administered with single dose of AEB071 |
NIL |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| to assess safety and tolerability of AEB071 during multiple dose administration in healthy subjects alone and when combined with caffeine |
NIL |
|
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Target Sample Size
|
Total Sample Size="18"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/09/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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|