A study to determine safety, pharmacokinetics and efficacy of the different doses of VL-SE-01 in healthy participants.
- Registration Number
- CTRI/2024/07/070717
- Lead Sponsor
- Vedic Lifesciences Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male & female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
2. Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
3. Individual has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18.5 to 29.9 kg/m2 (inclusive).
4. Individuals with a stressed lifestyle as assessed by PSS scores within 27-40.
5. A male must agree to use contraception during the intervention period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period.
6. A female is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
a) Not a woman of childbearing potential (WOCBP).
b) OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention.
1. Individual has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinology related, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention, or interfering with the interpretation of data.
2. Males who has a history of oligospermia, vasectomy and other sperm abnormalities.
3. Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.
4. Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.
5. Individuals with SBP more than or equal to 160 mmHg and DBP more than or equal to 100 mmHg.
6. Individuals on anti-hypertensives.
7. History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by:
a) For men, consuming more than 4 drinks on any day or more than 14 drinks/week
b) For women, consuming more than 3 drinks on any day or more than 7 drinks/week
8. Peri and post menopausal women with no menstrual cycle in the last 6 months.
9. Individuals with a history or actively under the influence of Hemp or CBD products by any means of administration.
10. Individual has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol.
11. Individual has a history of unexplained syncope or a family history of sudden death due to long QT syndrome.
12. Individual with a history and/or currently diagnosed of cancer like lymphoma, leukaemia, or any malignancy.
13. Individual has past or intended use of prohibited medication or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing.
14. Individuals have taken sleep medication within 2 weeks prior to screening.
15. Individual has used hepatic enzyme-inducing drugs within 2 months prior to dosing.
16. Individuals has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) more than 1.5 times upper limit of normal (ULN).
17. Individual has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
18. Individual has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline.
19. Individual has a history of human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety of VL-SE-01 by assessing the Complete Metabolic Panel (CMP) before and after IP consumption.Timepoint: Day 0, Day 90 and Day 180
- Secondary Outcome Measures
Name Time Method