This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Rambam Health Care Campus

Information provided by (Responsible Party):

Kite Systems

ClinicalTrials.gov Identifier:

NCT02729623

First received: March 27, 2016

Last updated: July 22, 2016

Last verified: July 2016

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.

Healthy Drug: Kite Systems cannaHALER cannabis Inhaler. Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study

Primary Outcome Measures:

  • Δ9-tetrahydrocannabinol levels (THC) [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
  • Adverse event monitoring [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
  • Δ9 Carboxy-THC levels [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Short Blessed cognitive Test [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
  • Pulse rate [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
  • Oxygen saturation [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Experimental: Single CannaHALER dose 10 ± 0.1 mg

Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Drug: Kite Systems cannaHALER cannabis Inhaler.
Experimental: Single CannaHALER dose 15 ± 0.1 mg

Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Drug: Kite Systems cannaHALER cannabis Inhaler.
Experimental: Single CannaHALER dose 20 ± 0.1 mg

Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Drug: Kite Systems cannaHALER cannabis Inhaler.
Experimental: Single CannaHALER dose 25 ± 0.1 mg

Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.

Drug: Kite Systems cannaHALER cannabis Inhaler.

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • aged 30-70 years;
  • healthy
  • if applicable, negative pregnancy test (β 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02729623

Kite Systems

Rambam Health Care Campus

Principal Investigator: Ofir Ben-Ishay, MD. Rambam Health Care Campus

Responsible Party: Kite Systems
ClinicalTrials.gov Identifier: NCT02729623     History of Changes
Other Study ID Numbers: cannaHALER-1A 
Study First Received: March 27, 2016
Last Updated: July 22, 2016
Health Authority: Israel: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Undecided

ClinicalTrials.gov processed this record on September 13, 2016