Evaluation of the Pharmacokinetics of Prana P1 Capsules

An Open Label ,Phase I, 2-way Crossover Study Evaluating the Pharmacokinetics of Prana P1 THC Activated Capsules

This is a single dose clinical trial to assess the Pharmacokinetics of two (2) dosages; 10 mg and 20mg of THC: THCa of Prana P1 bionutrients in healthy volunteers.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: P1

Detailed Description

Single oral dose, (10 mg Prana P1 or 20 mg Prana P1) in each period with a washout of 30 days between doses. Patents will be randomly assigned dose for the first round of the study after a thirty-day washout, patient will return to the study site and receive cross over dose.

Metabolites to be Measured:

1. THC
2. 11-OH-THC [primary secondary metabolite of THC, psychoactive]
3. THC-COOH [inactive metabolite]

The following parameters for THC, 11-OH-THC, and THC-COOH will be assessed: AUC0-t, AUC0-inf, Cmax, AUCt/inf, Tmax.

Safety will be monitored and assessed through adverse events reports, 12-lead ECG, vital signs and laboratory parameters. Each participant will undergo a psychometric evaluation using the CHAT assessment tool.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Jamaica
  • Kingston, Jamaica, 7
    • Tropical Metabolism Research Unit, Caribbean Institute for Health Reserach, University of the West Indies, Mona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males between 18 and 55 years.
• Body weight with a Body Mass Index (BMI) range of 18.5 to 27.0 [or weight within 15% of ideal weight for participant's height and frame
• Healthy, with normal findings in the physical examination and vital signs (BP between 100-140/60-90 mmHg, Heart rate (HR) between 60 to 90 beats/min, respiration between 12 to 24 breaths/min) and no clinically-significant findings in a 12-lead ECG.
• No clinical laboratory values outside of the laboratory normal reference range, unless the investigator determines them to be not clinically significant.
• Negative for hepatitis B surface antigen, hepatitis C antibody, HIV --Willing and able to communicate well with the investigator and clinic staff, comply with the study procedure and schedule, and provide written informed consent.
• Able to understand the requirements of the study and sign Informed Consent.

Exclusion Criteria:

• Current major Axis I psychiatric disorder for which the participant is currently receiving treatment or which would make study compliance an issue.
• Any condition or therapy that, in the opinion of the investigator, may be significantly worsened by the exposure to marijuana.
• Acute disease at the time of enrolment (i.e., presence of a moderate or severe illness or infection with or without a fever).
• Febrile illness (oral temperature >37.6° C at the time of drug administration).
• Unstable chronic illnesses.
• Chronic liver, renal or inflammatory bowel disease or collagen vascular disease.
• Clinically significant elevation of Alanine transaminase(ALT) and/or Aspartate transaminase (AST).
• Active neurological disorder.
• Clinically significant uncontrolled illness or clinically significant surgery within 4 weeks prior to administration of study drug.
• Cancer within the previous 5 years, other than squamous cell or basal cell carcinoma of the skin.
• Difficulty to swallow study medication.
• Smoking more than 25 cigarettes per day.
• History of any clinical laboratory abnormality deemed significant by the Principal Investigator.
• History of serious adverse reaction or hypersensitivity to any drug.
• Bleeding tendency resulting from disease or medication rendering blood collection or the injection itself unsafe (use of antiplatelet agents is allowed).
• Coagulation disorders or receiving anticoagulant therapy.
• Inability to tolerate abstinence from caffeine for 24 hours prior to and during the study treatment phase.
• Consumption of alcohol within 24 hours prior to dosing and during the treatment phase.
• History of significant alcohol or drug abuse within one year prior to the screening visit
• Chronic use (i.e., ≥3 days per week) of marijuana based products within 3 months prior to the screening visit.
• Use of hard recreational drugs (such as cocaine, phencyclidine [PCP] and crack) within one year prior to the screening visit.
• Donation of plasma (500 mL) within 7 days prior to drug administration
• Any known or suspected allergy to any constituent of marijuana.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigators, contraindicates the participant 's participation in this study.
• Use of any investigational or non-registered drug or participation in an investigational study within 30 days prior to administration of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10 mg P1; 10 mg of P1 will be administered and compared with an active dose of 20 mg P1 on crossover	Drug: P1; 10 mg or 20 mg of THC:THCa; Other Names: THC:THCa (delta 9-tetrahydrocannabinol ); Prana P1
Active Comparator: 20 mg P1; 20 mg of P1 will be administered and compared with an active dose of 10 mg P1 on crossover	Drug: P1; 10 mg or 20 mg of THC:THCa; Other Names: THC:THCa (delta 9-tetrahydrocannabinol ); Prana P1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration( Cmax) of following a single dose of 10 mg Prana 1	Maximum plasma concentration of Prana P1 following a single dose of 10 mg of Prana P1; Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC.Pk endpoints of THC(0-48 hours post-dose); PK endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (T- 0-24 hours post-dose) Mean Cmax of 11-OH-THC. Mean AUC(0-t)) of 11-OH-THC.; PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.	At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs
Peak Plasma Concentration( Cmax) of following a single dose of 20 mg Prana 1	Maximum plasma concentration of Prana P1 following a single dose of 20 mg of Prana P1; Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC.Pk endpoints of THC(0-48 hours post-dose); PK endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (T- 0-24 hours post-dose) Mean Cmax of 11-OH-THC. Mean AUC(0-t)) of 11-OH-THC.; PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.	At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment related adverse events as assessed by CTCAE v 5.0	Number of participants who experience at least one adverse event during the treatment phase relative to the pre-treatment baseline, is presented. The number of participants with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline. (Time Frame: screening to follow-up 30 days) 5. The number of participants with a clinically significant change in vital signs, relative to pre-treatment baseline. From screening to follow-up of 30 days) 6.The number of participants with clinically significant changes in indices of the CHAT assessment tool.	up to 30 days post dose
Number of participants who discontinue treatment due to side effects	Number of participants who discontinue study drug due to adverse events during treatment .	up to 30 days

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: Marvin Reid, MBBS, Caribbean Institute for Health Research, University of the West Indies

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): January 23, 2019
• Study Completion (Anticipated): August 23, 2019

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: cannabis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: PR0PK1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No