The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler

Healthy Clinical Trial

Official title:

The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02729623
• Other study ID #: cannaHALER-1A
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: March 27, 2016
• Last updated: July 22, 2016
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: July 2016
• Source: Kite Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological treatment for neuropathic pain. The objective of this study is to explore the pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler, (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg / 20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis Inhaler device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events will be monitored following the inhalation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• aged 30-70 years;

• healthy

• if applicable, negative pregnancy test (ß human chorionic gonadotropin pregnancy test).

Exclusion Criteria:

• significant cardiac or pulmonary disease,

• history of a psychotic or anxiety disorder,

• pregnancy, pregnancy attempt or breastfeeding,

• presence of a neuropathic or non-neuropathic pain,

• low blood pressure, below 90 mm Hg (systolic)

• Diabetes is diagnosed,

• first degree family history of psychotic or anxiety disorder,

• history of drug addiction,

• history of drug misuse,

• using the following drugs: Rifampicin, Rifabutin, Carbamazepine, Phenobarbital, Primidone,

• using the following plants: Hypericum perforatum, troglitazone,

• Alcohol consumption up to 12 hours before the study,

• abnormal parameters such as Heart Rate above 100 BPM, Blood pressure, below 90 mm Hg (systolic), Saturation below 91 percent,

• Cannabis use up to 12 hours before the study,

• health condition which could affect or alter the experiment results,

• Volunteer has a legal guardian.

• Chronic use of drugs,

• age less than 30 or more than 70,

• a health condition that could affect the outcome of the trial or constitutes a risk factor for participation in the trial.

• The experiment will not include special populations such as pregnant women, children and without judgement.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Kite Systems cannaHALER cannabis Inhaler.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kite Systems	Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?9-tetrahydrocannabinol levels (THC)		30 Minutes	No
Primary	Adverse event monitoring		4 hours	Yes
Primary	?9 Carboxy-THC levels		30 Minutes	No
Secondary	Short Blessed cognitive Test		30 Minutes	No
Secondary	Blood pressure		120 Minutes	No
Secondary	Pulse rate		120 Minutes	No
Secondary	Oxygen saturation		120 Minutes	No