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Healthy VolunteersPhase 1NCT04314804

Safety and Pharmacokinetics of Smoked Cannabis in Healthy Patients

A Phase 1 study testing PPP001 in people with Healthy Volunteers, run by Tetra Bio-Pharma at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

No actual human data for pharmacokinetics, metabolism, safety, pharmacodynamics, nor efficacy parameters are available for inhaled medical cannabis. This study was designed to investigate the innocuity and tolerability levels as well as the pharmacokinetic profile of this combination when smoked/inhaled as intended in… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PPP001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteCanada
Study dates
1 Mar 2017to 16 Nov 2017
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Adult male and female patients at least 18 years of age
  • Normal cognitive status according to MDAS and MiniCogSubject agreed to follow the protocol
  • Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
  • Normal renal function (defined as serum creatinine level <133 μmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60)
  • The patient is able to perform deep inhalations and hold breath for at least 5 to 10 seconds. If there is any pulmonary disease diagnosed previously (obstructive and/or restrictive pathology), the patient must be able to perform a maximal inhalation of at least 12-15 ml/kg measured with an incentive spirometer, followed by a normal exhalation
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  • Ability to read and respond to questions in French or English.
  • A female volunteer must meet one of the following criteria:
  • If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose. An acceptable method of contraception includes one of the following:
  • Abstinence from heterosexual intercourse
  • Systemic contraceptives (birth control pills, injectable/implant/ insertable hormonal birth control products, transdermal patch)
  • Intrauterine device (with or without hormones)
  • Condom with spermicide or condom with intravaginally applied spermicide If of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least one year without menses)
  • A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must meet the following criteria:
  • Participant is unable to procreate, defined as surgically sterile (i.e. has undergone a vasectomy within the last 6 months)
  • Participant agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration. An acceptable method of contraception includes one of the following:
  • Abstinence from heterosexual intercourse. B. Condom with spermicide or condom with intravaginally applied spermicide

Who cannot join

  • Previous serious adverse event or hypersensitivity to cannabis or cannabinoids
  • Inability to understand and comply with the instructions of the study
  • Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
  • Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
  • Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5
  • Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids
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  • Current or history of suicidal ideation according to the Columbia- Suicide Severity Rating Scale (C-SSRS) approved by FDA in 2012 for assessment of suicidal ideation and behaviour
  • Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)
  • Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level >133 μmol/ L, Estimated Glomerular Filtration Rate (eGFR) <60)
  • Cognitive impairment according to MDAS and MiniCog
  • Epilepsy
  • The patient is currently using or has used cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
  • Positive urine drug screen for cannabinoids and other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines, hallucinogens, unprescribed opioids and ketamine, etc.)
  • Participation in another clinical trial within 30 days of enrolment in our trial

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Algorithme Pharma.

    Montreal, Quebec, H2L 3K9

Other trials in Canada

About this study

Official title: A Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9- Tetrahydrocannabinol/Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers/Fasting State

No actual human data for pharmacokinetics, metabolism, safety, pharmacodynamics, nor efficacy parameters are available for inhaled medical cannabis. This study was designed to investigate the innocuity and tolerability levels as well as the pharmacokinetic profile of this combination when smoked/inhaled as intended in clinical therapeutic use (i.e. patients with neuropathic pain). Consecutive dosing (over a period of 7 days) should allow to test the tolerability of chronic administration. In addition, the impact of the THC/cannabidiol pharmacological activity on the cognition activity, cognitive test will be performed before and throughout the treatment and compared to the plasma levels of THC/cannabidiol following single and multiple dosing.

Being tested
PPP001, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PPP001Combination product

    Also called titanium pipe

    1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)

  • PlaceboCombination product

    Also called titanium pipe

    1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)

Study groups in NCT04314804
Study groupRoleWhat they receive
Smoked cannabis (PPP001)Experimental280 mg dried cannabis pellet -(9% THC / 2% CBD per pellet)
Receives: Combination Product: PPP001
THC free placeboPlacebo comparator280 mg dried extracted cannabis pellet (0% THC / 0.6% CBD per pellet)
Receives: Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

    Safety and tolerability of smoked PPP001-kit will be measured

    Measured: over the 7-day trial

Secondary outcomes (5)

  1. Peak Plasma Concentration (Cmax)

    Measured: over the 7-day trial

  2. Time to peak plasma concentration,

    Measured: over the 7-day trial

  3. Area under the plasma drug concentration versus time curve,

    Measured: over the 7-day trial

  4. Apparent terminal elimination rate constant,

    Measured: over the 7-day trial

  5. Apparent terminal elimination half-life,

    Measured: over the 7-day trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2020
  2. Study start1 Mar 2017
  3. Primary completion8 Nov 2017
  4. Study completion16 Nov 2017

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04314804
Sponsor's protocol ID
PPP001-Ph1-02
Status last verified
Mar 2020
First submitted
9 Mar 2020
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PPP001 in people with Healthy Volunteers, run by Tetra Bio-Pharma at 1 site in Canada.

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 17 inclusion and 14 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: finished, as of the sponsor's last update on 25 Mar 2020. 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 Canada. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Treatment-Emergent Adverse Events (time frame: over the 7-day trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04314804.

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 25 Mar 2020.

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Clinical Trial NCT04314804 | AzTrials