Evaluation of the Pharmacokinetics of Prana P1 Capsules

• ClinicalTrials.gov Identifier: NCT03744091
• Recruitment Status: Unknown
• First Posted: November 16, 2018
• Last Update Posted: June 7, 2019
• Sponsor: The University of The West Indies
• Information provided by (Responsible Party): Shelly Rosemarie McFarlane, The University of The West Indies

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: P1	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will be randomly assigned to either 10 mg or 20mg arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label ,Phase I, 2-way Crossover Study Evaluating the Pharmacokinetics of Prana P1 THC Activated Capsules
• Actual Study Start Date: July 16, 2018
• Actual Primary Completion Date: January 23, 2019
• Estimated Study Completion Date: August 23, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Peak Plasma Concentration( Cmax) of following a single dose of 10 mg Prana 1 [ Time Frame: At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs ]

   Maximum plasma concentration of Prana P1 following a single dose of 10 mg of Prana P1

   1. Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC.

      Pk endpoints of THC(0-48 hours post-dose)

   2. 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.
   3. PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.
2. Peak Plasma Concentration( Cmax) of following a single dose of 20 mg Prana 1 [ Time Frame: At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs ]

   Maximum plasma concentration of Prana P1 following a single dose of 20 mg of Prana P1

   1. Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC.

      Pk endpoints of THC(0-48 hours post-dose)

   2. 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.
   3. PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.

Secondary Outcome Measures :

1. Number of participants with treatment related adverse events as assessed by CTCAE v 5.0 [ Time Frame: up to 30 days post dose ]

   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.

2. Number of participants who discontinue treatment due to side effects [ Time Frame: up to 30 days ]
   Number of participants who discontinue study drug due to adverse events during treatment .

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Jamaica

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

Kingston, Jamaica, 7

Sponsors and Collaborators

The University of The West Indies

Investigators

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

More Information

• Responsible Party: Shelly Rosemarie McFarlane, Coordinating Investigator, The University of The West Indies
• ClinicalTrials.gov Identifier: NCT03744091
• Other Study ID Numbers: PR0PK1
• First Posted: November 16, 2018
• Last Update Posted: June 7, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shelly Rosemarie McFarlane, The University of The West Indies:

cannabis

Additional relevant MeSH terms:

Dronabinol; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists