A Study of Mangoral in healthy humans
- Registration Number
- CTRI/2021/03/031719
- Lead Sponsor
- Ascelia Pharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
(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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the PK and PD of mangoral in healthy human subjects in fasting and fed (full meal or snacks) conditionsTimepoint: 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. <br/ ><br>Blood samples at pre-dose (0.0) and up to 24 hours post dose will be collected at the MRI facility
- Secondary Outcome Measures
Name Time Method To assess the safety of mangoral after a single oral administration in healthy human subjects in fasting and fed conditions (full meal or snack).Timepoint: 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. <br/ ><br>MRI- prior to administration of dose and post-dose at 1 ± 0.5, 4 ± 0.5, 8 ± 0.5, and 24 ± 0.5 hours <br/ ><br>