| CTRI Number |
CTRI/2021/03/032206 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMICS OF
AT-10 IN HEALTHY HUMAN SUBJECTS CONSIDERED AS EXTENSIVE AND POOR
METABOLIZERS BASED ON CYP2C19 GENOTYPE |
|
Scientific Title of Study
|
A PHASE 1 OPEN LABEL, RANDOMIZED, TWO-PERIOD, SINGLE AND MULTIPLE-DOSE,
SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMIC, STUDY OF
AT-10 IN HEALTHY HUMAN SUBJECTS CONSIDERED AS EXTENSIVE AND POOR
METABOLIZERS OF CYP2C19 BASED ON GENOTYPING |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CBCC/2019/003, Version 01, dated 08 March 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aashutosh Patel |
| Designation |
Principal Investigator |
| Affiliation |
CBCC Global Research LLP |
| Address |
Clinical Pharmacology Unit
CBCC Global Research LLP
Skoda House, Opp. L.J. Campus
S. G. Highway, Sarkhej, Ahmedabad,India
Ahmadabad
GUJARAT
382210
India |
| Phone |
9726434240 |
| Fax |
|
| Email |
dr.aashutosh22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Pareek |
| Designation |
President, Medical Affairs and Clinical Research |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Ipca Laboratories Limited, 142AB Kandivli Industrial Estate, Kandivli(W), Mumbai MAHARASHTRA India
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02266474641 |
| Fax |
02228686954 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Chandurkar |
| Designation |
Vice President, Clinical Research and Development |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Ipca Laboratories Limited, 142AB Kandivli Industrial Estate Kandivli(W) Mumbai MAHARASHTRA India
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02266474622 |
| Fax |
02228686954 |
| Email |
nitin.chandurkar@ipca.com |
|
|
Source of Monetary or Material Support
|
| Ipca Laboratories Limited, Mumbai |
|
|
Primary Sponsor
|
| Name |
Ipca Laboratories Limited |
| Address |
142 AB, Kandivli Industrial Estate,
Kandivli (West), Mumbai - 400 067, Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Singh |
CBCC Global Research LLP |
Clinical Pharmacology Unit
CBCC Global Research LLP
Skoda House, Opp. LJ Campus
S. G. Highway, Sarkhej, Ahmedabad - 382 210, India
Ahmadabad
GUJARAT |
9637555304
9726434204
sandeep.singh@cbccusa.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Poor and Extensive metabolizers of CyP2C19 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AT -10 (2-Oxo Clopidogrel) |
AT -10 40mg OD on Day 1
AT -10 10 mg OD on Days, 2, 3, 4, 5 &
6 |
| Comparator Agent |
Clopidogrel |
Clopidogrel 300 mg OD on Day 1
Clopidogrel 75 mg OD on Days 2, 3, 4, 5 & 6 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects who are willing to provide voluntary informed consent and are willing to participate in the study.
2) Normal healthy human adult male and/or female subjects between 18-45 years (both ages
inclusive) of age.
3) Body Mass Index of 18.50 to 29.90 kg/m2 (both inclusive).
4) No evidence of underlying disease during the pre-study screening, medical history, clinical
examination and laboratory investigations performed within 28 days prior to commencement of the
study.
5) Subject classified as extensive (normal) metabolizer or poor metabolizer based on CYP2C19 allele 1, 2, 3 and 17 genotyping.
6) Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study.
7) Negative test results for alcohol, drugs of abuse, Beta hCG test (for female subjects only) and who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR at the time of screening.
8) 12-lead ECG recording within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his/her participation in the study. |
|
| ExclusionCriteria |
| Details |
1) Known allergic to Clopidogrel, AT-10 or any component of the formulation and to any other
related class of drug.
2) History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
3) Female subjects who are nursing motherslactating women.
4) History/presence of significant alcohol dependence (abuse) or drug abuse within the past 1 year.
5) History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products.
6) History/presence of significant Asthma, urticaria or other allergic type reactions after taking any medication.
7) History/presence of clinically significant illness within 04 weeks before the start of the study.
8) History/presence of significant Hypersensitivity to heparin.
9) History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
9) Platelet count outside the normal range at screening or housing for Period 1
10) Subjects scheduled for surgery any time during study or within 07 days after study completion.
11) Subjects who have taken prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP, including topical medication.
12) Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication (e.g. Omeprazole or other proton pump inhibitors). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
safety and tolerability of AT-10 compared to Clopidogrel administered orally to humans.
effect of AT -10 (loading and maintenance doses) Vs the approved doses of Clopidogrel (loading and maintenance doses) on
platelet aggregation in poor and extensive metabolizers.
|
6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
single and multiple dose pharmacokinetics (PK) of
Clopidogrel, AT -10, and active metabolite MP-H4 |
6 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="27" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Phase 1 Open Label, Randomized, Two-Period, Single and Multiple-Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic, Study of AT-10 in Healthy Human Subjects considered as Extensive and Poor Metabolizers of CYP2C19 based on Genotyping. 40 healthy adult Indian human subjects who are randomized in 1:1 ratio as poor and extensive metabolizers will be given AT-10 or Clopidogrel loading and maintenance doses over 6 days. The primary outcome will be to check the safety and tolerability of AT -10 compared to Clopidogrel and their effect on platelet aggregation in poor and extensive metabolizers. |