| CTRI Number |
CTRI/2018/09/015576 [Registered on: 04/09/2018] Trial Registered Prospectively |
| Last Modified On: |
19/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A safety and tolerability study of Sodium Copper Chlorophyllin in healthy, adult human male subjects. |
|
Scientific Title of Study
|
AN OPEN LABEL, CLINICAL STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SODIUM COPPER CHLOROPHYLLIN IN HEALTHY ADULT, HUMAN MALE SUBJECTS.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 0462-16,Version 1.0 Dated 28 January 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Patel |
| Designation |
Assistant General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Department of Clinical Pharmacology and Medical Affairs, Plot no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202488 |
| Fax |
07940202021 |
| Email |
akashpatel@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Gota |
| Designation |
Medical Expert |
| Affiliation |
Tata Memorial Centre |
| Address |
ACTREC, Sector 22, Utsav Chowk - CISF Road,
Owe Camp,Kharghar,Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
02227405000 |
| Fax |
|
| Email |
vikramgota@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shivkumar Madki |
| Designation |
Managing Director |
| Affiliation |
IDRS Labs Private Limited |
| Address |
No. 235-H, Phase 3
Bommasandra Industrial Area, Hosur Road
Bangalore
KARNATAKA
560099
India |
| Phone |
08045459595 |
| Fax |
|
| Email |
shiv.madki@idrslabs.com |
|
|
Source of Monetary or Material Support
|
| IDRS Labs Private Limited, No. 235-H, Phase 3, Bommasandra Industrial Area, Hosur Road, Bangalore – 560 099, Karnataka, India, Tel No.: 08045459595 |
|
|
Primary Sponsor
|
| Name |
IDRS Labs Private Limited |
| Address |
No. 235-H, Phase 3, Bommasandra Industrial Area, Hosur Road, Bangalore – 560 099, Karnataka, India, Tel No.: 08045459595 |
| 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 Akash Patel |
Lambda Therapeutic Research Ltd |
Lambda House, Department of Clinical Pharmacology and Medical Affairs, Plot
no. 38, Survey No. 388
Near Silver Oak Club,
S. G. Highway,
Gota-382481
Ahmadabad
GUJARAT |
07940202488
akashpatel@lambda-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee, Dr. Akash Patel |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ADULT, HUMAN MALE SUBJECTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Sodium Copper Chlorophyllin of IDRS Labs Pvt. Ltd. Bengaluru, India |
Dose: 1500 mg, 3000 mg, 6000 mg given in two divided dosage; Frequency: morning & evening; Mode of Administration:
Oral; Duration of treatment: One day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
i. Non-smoker, Healthy, adult, human male volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
ii. Having a Body Mass Index (BMI) between 18.5 to 24.9 (both inclusive), calculated as weight in kg/height in meter square.
iii. Have no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
iv. Able to understand and comply with the study procedures, in the opinion of the investigator.
v. Able to give voluntary informed consent for participation in the trial. |
|
| ExclusionCriteria |
| Details |
i. Known hypersensitivity or idiosyncratic reaction to Sodium Copper Chlorophyllin or to any of its excipients or any drug or any substance.
ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
iii. Ingestion or Use of any medication [prescribed & over the counter (OTC) medication including herbal remedies] at any time within 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator.
iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID (i.e. ibuprofen, aspirin) induced urticaria.
v. Consumption of grapefruits or grapefruits products within a period of 72 hours prior to dosing.
vi. A recent history of harmful use of alcohol(less than 2 years)
vii. Smokers, or who have smoked within last six months prior to start of the study.
viii. The presence of clinically significant abnormal laboratory values during screening.
ix. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
x. History or presence of psychiatric disorders.
xi. A history of difficulty with donating blood.
xii. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication.
xiii. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
xiv. A positive test result for HIV antibody (I & II).
xv. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug. In any such case subject selection will be at the discretion of the Principal Investigator. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The safety and tolerability of Chlorophyllin. |
During entire duration of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The pharmacokinetics, modulation of pharmacodynamic markers and food effect of Chlorophyllin (CHL) |
Day 1- Day 7 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
07/09/2018 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is being conducted to assess safety, tolerability, pharmacokinetics and pharmacodynamics of herbal molecule (Sodium Copper Chlorophyllin) in healthy adult, human male subjects. 15 Healthy Human Male subjects will be enrolled in the study. Subject will have to stay in the clinical facility for three consecutive nights in study period. In case of adverse events, necessary action will be taken until the event subsides. Three (3) cohorts of 5 healthy, adult human male volunteers between the ages of 18 and 45 years (both inclusive) will participate in this trial. A sufficient number of volunteers will be asked to report on the day of check-in of each cohort in order to ensure that at least 5 subjects will be enrolled in the beginning of the respective cohort. Subsequent dropouts after dosing in each cohort will not be replaced. Cohort 4 will be performed to evaluate the food effect on the same subjects from any one of the first 3 Cohorts based on the achieved maximum tolerated dose obtained from all 3 Cohorts. The data identifying each study subject by name will be kept confidential. |