Clinical trial NCT06324370: Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)
Official title: Bioequivalence of Virgin Coconut Oil (VCO) Among Healthy Filipino Male Adults: An Exploratory Pharmacokinetic Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pharmacological Action
Keywords: Pharmacokinetic Study
Bioequivalence
Virgin Coconut Oil
Filipino
Philippines
Lead sponsor: Food and Nutrition Research Institute, Philippines
Sponsor class: OTHER_GOV
Collaborators: name: Ateneo de Manila University
name: De La Salle Medical and Health Sciences Institute
First posted: 2024-03-22
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: This will be a two-sequence (single- and multiple-dose) pharmacokinetic study in healthy Filipino male human participants under fed conditions.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI).

Detailed description: Virgin coconut oil (VCO) will be administered with 240 ml water and standardized food on dosing periods, with a 5-day interval between the single-dose (0.6 ml/kg body weight) and the multiple-dose (1.2 ml/kg body weight divided into three doses daily) study periods. For the single-dose study, blood for PK analysis will be collected at pre-dose (-0.5 and 0 hours), then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. For the multiple-dose study, blood samples will be collected on the last day of dosing before the 2nd dose (at -0.5 and 0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. Sample collection will be continued after the last multiple dose at the following time points: 48, 72, 96, 120 and 144 hours. In addition, pre-dose blood samples will be collected daily from Day 8-12 to determine trough plasma concentrations and the approach to steady state. Blood samples will be sent to the Ateneo De Manila University (AdMU) for gas chromatography-mass spectrometry (GC-MS) analysis. Established primary and secondary endpoints for pharmacokinetics and safety and tolerability will be evaluated.

This study is necessary to establish human data on the pharmacokinetics of virgin coconut oil (VCO).

Eligibility criteria: Inclusion Criteria:

* Healthy Filipino male
* 18-45 years of age
* signed written informed consent obtained
* body-mass index of ≥18.5 kilogram per meter-squared (kg/m2) and ≤ 24.9 kg/m2, with body weight not less than 50 kilogram(kg)

Exclusion Criteria:

* history of allergy and/or sensitivity to virgin coconut oil, any of its constituents, or related drugs
* positive Coronavirus Disease (COVID-19) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test
* history of anaphylaxis or angioedema
* systolic Blood Pressure (BP) of less than 90 mm Hg and/or diastolic BP of less than 60 mm Hg
* pulse rate of less than 50 beats/minute
* body weight +/-15% optimum weight as related to height and body frame
* history of tuberculosis or use of anti-tuberculosis drugs within 6 months prior to entry into study clinically significant gastrointestinal, cardiovascular, renal, hepatic, endocrine, metabolic, neurologic, psychiatric, hematological or other abnormalities, as judged by the Investigator
* history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes
* gastrointestinal disorders which may impair drug absorption, or other conditions which could modify the absorption of the study drug, as judged by the Investigator clinically significant deviation in the clinical chemistries (liver and renal function tests) and hematology at visit 1 which may impair assessment, as judged by the Investigator
* positive pre-study urine drug screen
* positive/reactive Hepatitis B and human immunodeficiency virus (HIV)
* use of any prescription drug within 30 days or any over-the-counter (OTC) drug within 14 days prior to and during the study inaccessibility of veins in left and right arm donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
* subjects who cannot abstain from grapefruit, citrus fruits and food and/or beverages that contain caffeine or other xanthines
* an unusual diet, for whatever reason, e.g., low sodium diet, for two weeks prior to receiving any medication and throughout subject's participation in the study current smoker or smoking within two months prior to study enrollment
* consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol - one glass wine, half pint beer, and one measure/one ounce of spirit)
* participation in a clinical study within 3 months prior to visit 1
* significant illness during the 4 weeks preceding screening of the study
* having an occupation or requirement of driving a vehicle or operate a complex machinery before 21 days of taking the drug in both periods

Primary outcomes:
measure: Pharmacokinetics (AUC0-t)
timeFrame: 25 days
measure: Pharmacokinetics (Cmax)
timeFrame: 25 days
Secondary outcomes:
measure: Pharmacokinetics (AUC0-inf)
timeFrame: 25 days
measure: Pharmacokinetics (tmax)
timeFrame: 25 days
measure: Pharmacokinetics (Kel)
timeFrame: 25 days
measure: Pharmacokinetics (t1/2)
timeFrame: 25 days
measure: Vital Signs (Systolic and Diastolic Blood Pressure)
timeFrame: 25 days
measure: Vital Signs (Pulse rate)
timeFrame: 25 days
measure: Vital Signs (Body temperature)
timeFrame: 25 days
measure: Vital Signs (Respiratory rate)
timeFrame: 25 days
measure: Safety and Tolerability (Adverse events)
timeFrame: 25 days
measure: Post Study Evaluation (Fasting Blood Sugar Test)
timeFrame: 25 days
measure: Post Study Evaluation (Blood Urea Nitrogen Test)
timeFrame: 25 days
measure: Post Study Evaluation (Creatinine)
timeFrame: 25 days
measure: Post Study Evaluation (Uric Acid)
timeFrame: 25 days
measure: Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test)
timeFrame: 25 days
measure: Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test)
timeFrame: 25 days
measure: Post Study Evaluation (Alkaline Phosphatase Test)
timeFrame: 25 days
measure: Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test)
timeFrame: 25 days
measure: Post Study Evaluation (Indirect, Direct and Total Bilirubin)
timeFrame: 25 days
measure: Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides)
timeFrame: 25 days
measure: Post Study Evaluation (Lipase Test)
timeFrame: 25 days
measure: Post Study Evaluation (Amylase Test)
timeFrame: 25 days
measure: Post Study Evaluation (Complete Blood Count with Platelet Count Test)
timeFrame: 25 days
measure: Post Study Evaluation (Complete Urinalysis)
timeFrame: 25 days
measure: Post Study Evaluation (Fecalysis)
timeFrame: 25 days
Other outcomes:
Locations:
city: Taguig
country: Philippines
facility: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
state: Metro Manila
Study officials:
affiliation: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
name: Carl Vincent D. Cabanilla, Bachelor's
role: PRINCIPAL_INVESTIGATOR
References: