Evaluation of the Pharmacokinetics of Prana P1 Capsules

NCT ID: NCT03744091

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2019-08-23

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 mg P1

10 mg of P1 will be administered and compared with an active dose of 20 mg P1 on crossover

Group Type: ACTIVE_COMPARATOR

P1

Intervention Type: DRUG

10 mg or 20 mg of THC:THCa

20 mg P1

20 mg of P1 will be administered and compared with an active dose of 10 mg P1 on crossover

Group Type: ACTIVE_COMPARATOR

P1

Intervention Type: DRUG

10 mg or 20 mg of THC:THCa

Interventions

P1

10 mg or 20 mg of THC:THCa

Intervention Type: DRUG

Other Intervention Names

THC:THCa (delta 9-tetrahydrocannabinol ); Prana P1

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of The West Indies

OTHER

Sponsor Role: lead

Responsible Party

Shelly Rosemarie McFarlane

Coordinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marvin Reid, MBBS

Role: PRINCIPAL_INVESTIGATOR

Caribbean Institute for Health Research, University of the West Indies

Locations

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

Kingston, , Jamaica

Countries

Jamaica

Other Identifiers

PR0PK1

Identifier Type: -

Identifier Source: org_study_id