Clinical trial NCT06473246: A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Population
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind and Placebo controlled
Primary purpose: OTHER

Brief summary: The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout/withdrawal rate of 25%. The intervention duration for all the study participants is 180 days.


Eligibility criteria: Inclusion Criteria:

* Male \& female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* 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)
* Individuals with a stressed lifestyle as assessed by PSS scores within 27- 40.
* 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.
* A female is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

  1. Not a woman of childbearing potential (WOCBP)
  2. OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention

Exclusion Criteria:

* 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.
* Males who has a history of oligospermia, vasectomy and other sperm abnormalities.
* Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.
* Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.
* Individuals with SBP ≥ 160 mmHg and DBP ≥ 100 mmHg.
* Individuals on anti-hypertensives.
* History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by:

  1. For men, consuming more than 4 drinks on any day or more than 14 drinks/week
  2. For women, consuming more than 3 drinks on any day or more than 7 drinks/week
* Peri and post-menopausal women with no menstrual cycle in the last 6 months
* Individuals with a history or actively under the influence of Hemp or CBD products by any means of administration
* 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
* Individual has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
* Individual with a history and/or currently diagnosed of cancer like lymphoma, leukaemia, or any malignancy.
* 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
* Individuals have taken sleep medication within 2 weeks prior to screening
* Individual has used hepatic enzyme-inducing drugs within 2 months prior to dosing
* Individuals has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.5 times upper limit of normal (ULN)
* Individual has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Individual has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline
* Individual has a history of human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.

Primary outcomes:
measure: To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day -5 to Day -1
measure: To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day 90
measure: To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day 180
measure: To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day -5 to Day -1
measure: To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day 90
measure: To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day 180
measure: To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day -5 to -1
measure: To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day 90
measure: To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
timeFrame: Day 180
Secondary outcomes:
measure: To assess the safety and tolerability of VL-SE-01 using blood, which includes Complete Blood Count (CBC).
timeFrame: Day -5 to Day -1, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 using blood, which includes Inflammation by analyzing CRP levels.
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 using blood, which includes Hormonal profile (Luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, estradiol and progesterone)
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 using blood, which includes Thyroid profile (T3, T4, TSH)
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 using blood, which includes Lipid Profile as assessed by levels of total cholesterol, LDL, HDL and triglycerides
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 on Semen.
timeFrame: Day -5 to Day -1 and Day 180
measure: To assess the safety and tolerability of VL-SE-01 using blood Plasma levels of CBD and its metabolites [7-Carboxy-cannabidiol (7-COOH-CBD) and 7-Hydroxy-cannabidiol (7-OH-CBD)]
timeFrame: Day 195 (single timepoint)
measure: To assess the safety and tolerability of VL-SE-01 on Blood Pressure.
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 on Pulse Rate.
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 using Electrocardiogram.
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To assess the safety and tolerability of VL-SE-01 using Treatment emergent Adverse Events (TEAEs).
timeFrame: Day 0, Day 90, Day 180 and Day 195
measure: To evaluate the efficacy of VL-SE-01 on the basis of Incidence of gastrointestinal dysfunction using Structured Assessment of Gastrointestinal Symptoms (SAGIS) questionnaire.
timeFrame: Day 0, Day 90, and Day 180
measure: To evaluate the efficacy of VL-SE-01 on the basis of Sleep quality using the PSQI questionnaire
timeFrame: Day 0, Day 90, and Day 180
measure: To evaluate the efficacy of VL-SE-01 on the basis of Insomnia using Insomnia Severity Index (ISI)
timeFrame: Day 0, Day 90, and Day 180
measure: To evaluate the efficacy of VL-SE-01 on the basis of Fatigue will be assessed using fatigue severity scale (FSS)
timeFrame: Day 0, Day 90, and Day 180
measure: To evaluate the efficacy of VL-SE-01 on the basis of Stress response as assessed by Perceived Stress Scale (PSS).
timeFrame: Day 0, Day 90, and Day 180
measure: To evaluate the efficacy of VL-SE-01 on the basis of Menstrual cycle regularity.
timeFrame: Day 0, Day 90, and Day 180
measure: To evaluate the efficacy of VL-SE-01 on the basis of Plasma levels of CBD and its metabolites [7-Carboxy-cannabidiol (7-COOH-CBD) and 7-Hydroxy-cannabidiol (7-OH-CBD)]
timeFrame: 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours at Day 0, Day 90, Day 180
Other outcomes:
Locations:
city: Dombivli
country: India
facility: Shivam Hospital
state: Maharashtra
city: Pune
country: India
facility: Dhanwantri Hospital
state: Maharashtra
city: Pune
country: India
facility: Vedant Multispeciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Punawale Hospital
state: Maharashtra
city: Pune
country: India
facility: Vishwaraj Hospital
state: Maharashtra
city: Thane
country: India
facility: Shree Ashirwad Hospital
state: Maharashtra
Study officials:
References: