HealthyPhase 1NCT03744091
Evaluation of the Pharmacokinetics of Prana P1 Capsules
A Phase 1 study testing P1 in people with Healthy, run by The University of The West Indies at 1 site in Jamaica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- P1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteJamaica
- Study dates
- 16 Jul 2018to 23 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Jamaica1 site
Tropical Metabolism Research Unit, Caribbean Institute for Health Reserach, University of the West Indies, Mona
Kingston, 7
About this study
Official title: 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.
Read the 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:
- THC
- 11-OH-THC [primary secondary metabolite of THC, psychoactive]
- 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
- Being tested
- P1
- Keywords
- cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1Drug
Also called THC:THCa (delta 9-tetrahydrocannabinol ), Prana P1
10 mg or 20 mg of THC:THCa
| Study group | Role | What they receive |
|---|---|---|
| 10 mg P1 | Active comparator | 10 mg of P1 will be administered and compared with an active dose of 20 mg P1 on crossover Receives: Drug: P1 |
| 20 mg P1 | Active comparator | 20 mg of P1 will be administered and compared with an active dose of 10 mg P1 on crossover Receives: Drug: P1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs
Secondary outcomes (2)
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.
Measured: 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 .
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start16 Jul 2018
- Primary completion23 Jan 2019
- Study completion23 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to either 10 mg or 20mg arm
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelly Rosemarie McFarlane, The University of The West Indies
- Investigators
- Marvin Reid, MBBS, Principal investigator, Caribbean Institute for Health Research, University of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744091
- Sponsor's protocol ID
- PR0PK1
- Status last verified
- Jun 2019
- First submitted
- 1 Aug 2018
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label ,Phase I, 2-way Crossover Study Evaluating the Pharmacokinetics of Prana P1 THC Activated Capsules
- ClinicalTrials.gov ID
- NCT03744091
- Acronym / sponsor ID
- PR0PK1
- Conditions
- Healthy
- Keywords
- cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Aug 2019 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- THC
- 11-OH-THC [primary secondary metabolite of THC, psychoactive]
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either 10 mg or 20mg arm
| Arm | Type | Receives |
|---|---|---|
| 10 mg P1 | Active comparator | Drug: P110 mg of P1 will be administered and compared with an active dose of 20 mg P1 on crossover |
| 20 mg P1 | Active comparator | Drug: P120 mg of P1 will be administered and compared with an active dose of 10 mg P1 on crossover |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P1Also: THC:THCa (delta 9-tetrahydrocannabinol ), Prana P110 mg or 20 mg of THC:THCa | Drug | 10 mg P1, 20 mg P1 |
Primary outcome
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.
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.
2 secondary outcomes
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 discontinue treatment due to side effects
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marvin Reid, MBBS principal investigator
Caribbean Institute for Health Research, University of the West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P1 in people with Healthy, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.