| CTRI Number |
CTRI/2016/09/007251 [Registered on: 07/09/2016] Trial Registered Prospectively |
| Last Modified On: |
31/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of a drug called Propranolol on Melatonin (Melatonin is secreted by a gland in human body which regulates Sleep Cycle) |
|
Scientific Title of Study
|
To measure the level of melatonin (urinary 6-sulpha¬toxymelatonin (aMT6s) in healthy human volunteers who are receiving different dosing regimens of the beta blocker-Propranolol |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VIC/2016/001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Mittal |
| Designation |
Director Clinical Cardiology and Research |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta The Medicity
Sector 38
Gurgaon
Medanta The Medicity
Sector 38
Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
919910044477 |
| Fax |
|
| Email |
sanjay.mittal@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Md Muneeb Ahsan |
| Designation |
Project Leader |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta-The Medicity
Sector 38
Gurgaon
Medanta-The Medicity
Sector 38
Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
919818152572 |
| Fax |
|
| Email |
muneeb.ahsan@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Md Muneeb Ahsan |
| Designation |
Project Leader |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta-The Medicity
Sector 38
Gurgaon
Medanta-The Medicity
Sector 38
Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
919818152572 |
| Fax |
|
| Email |
muneeb.ahsan@medanta.org |
|
|
Source of Monetary or Material Support
|
| Research Grant Provided by Vicus Therapeutics Inc, USA |
|
|
Primary Sponsor
|
| Name |
Global Health Private Limited |
| Address |
Medanta The Medicity
Sector 38
Gurgaon |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vicus Therapeutics Inc |
Vicus Therapeutics
55 Madison Ave, Suite 400
Morristown, NJ 07960
USA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Mittal |
Medanta The Medicity |
Medanta Duke Research Institute
10th Floor, Medanta The Medicity, Sector 38, Gurgaon
Gurgaon
HARYANA |
919910044477
sanjay.mittal@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propranolol |
Arm 1 60 mg 9 AM (+ 30 min) |
| Comparator Agent |
Propranolol |
Arm 2 30 mg 9 AM (+ 30 min) and 3 PM (+ 30 min) |
| Comparator Agent |
Propranolol |
Arm 3 60 mg 6 PM (+ 30 min) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Signed, written Informed Consent
• Body Mass Index (BMI) 18.5-24.9 Kg/m2 (both inclusive)
• Men or Women aged 18 to 65 years (both inclusive)
• Healthy as determined by medical history, clinical and laboratory examination performed within 7 days before admission day (Day -2)
• In the opinion of the principal investigator / co-investigator, be able to comply with the study procedures and restrictions
• Adequate blood pressure (>110/60 mmHg) and heart rate (greater than 70 bpm)
• Adequate organ function as determined by the following laboratory values:
• ANC ≥1,500 /mcL
• Platelets ≥100,000 / mcL
• Hgb ≥10 g/dL
• Creatinine Clearance ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
• Total Bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
• AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
|
|
| ExclusionCriteria |
| Details |
• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the dose of treatment.
• Is already receiving propranolol or another beta-blocker
• Participants with history of sleep disturbance and have history of snoring
• Participants who is not able to understand or to comply with the study instructions and requirements or has a history of non-compliance to the medical regimen.
• Social Habits:
• Use of any tobacco products within 1 year of the start of the study and have difficulty in abstaining from its consumption
• Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication
• Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication
• Any recent, significant change in dietary or exercise habits
• A positive test for any drug included in the urine drug screen
• History of drug dependence and/or alcohol abuse
• Medications:
• Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the administration of study medication
• Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing
• Diseases:
• Participants with evidence of bradycardia (70 beats/min), resting hypotension (blood pressure 110/60 mmHg) or A-V block
• Participants with any evidence of severe or uncontrolled systemic disease (e.g. severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal disease [glomerulonephritis, nephritic syndrome, Fanconi Syndrome or Renal tubular acidosis]), or current unstable or uncompensated respiratory or cardiac conditions
• Has a history or current evidence of any condition (medical or surgical), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• History or presence of serious gastrointestinal, liver, kidney, heart, lung, neurological or blood disease, diabetes or glaucoma in the opinion of Principal Investigator/Co-investigator
• History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension etc.
• History or presence of any psychiatric illness
• A positive HIV, hepatitis B, or hepatitis C test
• History of asthma or other pulmonary problems
• Abnormal and clinically significant laboratory test results:
• Abnormal and clinically relevant ECG tracing
• Any clinically significant abnormality in Chest X-Ray
• Pregnant and lactating females
• Female subjects who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (double-barrier methods - any double combination of: IUD, male or female condom, spermicidal gel, diaphragm, sponge, cervical cap) during the study
• Male subjects who are not willing to use reliable contraceptive methods during the study
• Allergy or hypersensitivity to propranolol hydrochloride or other beta-adrenergic receptor-blocking agents
• History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption
• Consumption of grapefruit or grapefruit juice containing products within 7 days of drug administration
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the level of melatonin (urinary 6-sulpha¬toxymelatonin (aMT6s)) in healthy volunteers who are receiving different dosing regimens of the beta blocker propranolol |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure heart rate, blood pressure in patients receiving propranolol |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2016 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The eligible volunteers as per the inclusion and exclusion criteria will be admitted in the study at least 2 days before dose administration. On the dosing day a single oral dose of propranolol will be administered to each volunteer as per the following table;
|
Treatment Arm |
Propranolol dose
(Single Dose) |
Time |
|
Arm 1 |
60 mg |
9 AM (+ 30 min) |
|
Arm 2 |
30 mg twice |
9 AM and 3 PM (+ 30 min) |
|
Arm 3 |
60 mg |
6 PM (+ 30 min) |
The urine sample will be collected during the study in the following manner;
-
From 10AM until 10 PM on Day -1 “Day -1 (One day before Dosing of Propranolol), Daytime Urineâ€
-
From 10 PM on Day -1 until 10 AM on Day 0 (Dosing day), “Day -1, Nocturnal Urineâ€
-
From 10 AM on Day 0 until 10 PM on Day 0 “Day 0, Daytime Urineâ€
-
From 10 PM on Day 0 until 10 AM on Day 1 (Check-out Day), “Day 1, Nocturnal Urineâ€
The volunteers will be discharged 24 hrs after dose administration of single dose of Propranolol
This study will be conducted in 2 stages. In stage I, total 15 eligible volunteers will be admitted and dosed. After interim analysis of melatonin level in urine of 15 volunteers, next Stage II, will be initiated, where 30 eligible volunteers will be admitted and rest of the study procedures will be same as done for 15 volunteers |