| CTRI Number |
CTRI/2021/03/031719 [Registered on: 04/03/2021] Trial Registered Prospectively |
| Last Modified On: |
03/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study of Mangoral in healthy humans |
|
Scientific Title of Study
|
An Open Label, Randomized, Two-Period, Two-Way Crossover Study to Evaluate Effect of Food (Full Meal or Snack) on Mangoral after oral administration by assessing Pharmacokinetics and Pharmacodynamics in Healthy Adult Human Subjects |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 0188-20, Version 3.0, Dated: 28 May 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Prashant Modi |
| Designation |
Sr. General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Department of Project Management & Regulatory
Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway,Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202375 |
| Fax |
07940202021 |
| Email |
prashantmodi@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikrishna Kolte |
| Designation |
AGM |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Department of Clinical Pharmacology & Medical
Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway,Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202260 |
| Fax |
07940202021 |
| Email |
shrikrishnaskolte@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Prashant Modi |
| Designation |
Sr. General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Department of Project Management & Regulatory
Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway,Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202375 |
| Fax |
07940202021 |
| Email |
prashantmodi@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Ascelia Pharma AB, Hyllie Boulevard 34, 215 32 Malmö, Sweden |
|
|
Primary Sponsor
|
| Name |
Ascelia Pharma AB |
| Address |
Hyllie Boulevard 34, 215 32 Malmö, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Shrikrishna Kolte |
Lambda Therapeutic Research Limited |
Department of Clinical Research, Room No. NA, Lambda House, Plot
no. 38, Survey no. 388,
Near Silver Oak Club,
S.G. Highway,
Gota-382481
Ahmadabad
GUJARAT |
09594119900
shrikrishnaskolte@lambda-cro.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee (RMNH IEC), Dr. Shrikrishna Kolte |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adult Human Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manganese chloride tetrahydrate (MnCl2. 4H2O)(Stick pack 1 consist of 800 mg manganese chloride tetrahydrate and Stick Pack 2 consists of 500 mg L-alanine and 800 IU vitamin D3) |
Dose: 800 mg,
Frequency: Single Oral Dose,
Route of administration: Oral,
Duration of Therapy: Single day per period
Dosage Form: Powder for oral solution, Manufactured by Cambrex, Whippany, NJ, USA. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(a)Non-smoker, healthy, adult, human volunteers between 18 and 45 years of age (both inclusive).(b)Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg/height in m2.(c)Have no clinically significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, vital signs, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.(d)Able to understand and comply with the study procedures, in the opinion of the investigator.(e)Able to give voluntary informed consent for participation in the trial.(f)Volunteer who is literate.(g)In case of female subjects: (i)Surgically sterilized at least 6 months prior to study participation; and If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. Or (ii)Serum pregnancy test must be negative. |
|
| ExclusionCriteria |
| Details |
a) Known hypersensitivity or idiosyncratic reaction to IMP or to any of its excipients or any drug or any substance.
b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal and any other body systems.
c) The QTc interval more than 450 ms on ECG measurement at the time of screening.
d) Ingestion of a medicine [prescribed & over the counter (OTC) medication including herbal remedies] at any time within 2 weeks before first dosing (4 weeks for any drug which may affect hepatic drug metabolism). In any such case subject selection will be at the discretion of the Principal Investigator in consultation with Medical expert.
e) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
f) Consumption of Grapefruit or its products within a period of 72 hours prior to check-in of period-1.
g) Smokers or who have smoked within last 6 months prior to check-in of period-1.
h) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
i) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percent distilled spirits, such as rum, whisky, brandy etc) or Consumption of alcohol or alcoholic products within 48 hours prior to check-in of period-1.
j) Difficulty in drinking liquid dosage form.
k) The presence of clinically significant abnormal laboratory values during screening.
l) A history of difficulty with donating blood.
m) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of investigational medicinal product.
n) 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 investigational medicinal product.
If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
o) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
p) A positive test result for HIV antibody (1 and/or 2).
q) Nursing mothers (females).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the PK and PD of mangoral in healthy human subjects in fasting and fed (full meal or snacks) conditions |
The venous blood samples will be drawn at pre-dose (0.0) and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours following drug administration in each period.
Blood samples at pre-dose (0.0) and up to 24 hours post dose will be collected at the MRI facility |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of mangoral after a single oral administration in healthy human subjects in fasting and fed conditions (full meal or snack). |
Vital signs- prior to administration of dose and at 1, 3, 6, 9, 12, 24, 48 and 60 hours after administration of dose in each period.
MRI- prior to administration of dose and post-dose at 1 ± 0.5, 4 ± 0.5, 8 ± 0.5, and 24 ± 0.5 hours
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
08/03/2021 |
| 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="3"
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)?
Response - NO
|
|
Brief Summary
|
To evaluate effects of food on mangoral after a single oral administration in adult healthy subjects
Brief summary:
The current study is open label, randomized, two-period, two-way crossover study to evaluate effects of food (full meal or snack) on orally administered mangoral by assessing Pharmacokinetics (PK) and Pharmacodynamics (PD) of manganese in healthy adult human subjects.
Publication: Not Applicable |