INTERVENTIONALTERMINATEDNCT02240160

A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects

To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol (CBD)) by comparing the PK profile of Sativex in healthy subjects. The primary clinical hypothesis is that there will be an effect of oral pH on the PK of Sativex when administered as a single oromucosal dose (four sprays).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2021-02-05

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1
Enrollment: 6 (ACTUAL)
Start date: 2014-08
Sponsor: GW Pharmaceuticals Ltd
Design: RANDOMIZED · CROSSOVER · BASIC SCIENCE
Locations: 0
Results record: Not present in registry snapshot

This is a Phase I, randomised, open-label, three-way crossover study to assess the effects of oral pH on the PK of Sativex. Subjects will receive each of the following treatments in a random order across three residential treatment visits: * Treatment A (acidic oral pH): Sativex (four sprays) after pre-treatment with Coca-Cola; * Treatment B (neutral oral pH): Sativex (four sprays) after pre-treatment with tap water; * Treatment C (alkaline oral pH): Sativex (four sprays) after pre-treatment with an oral suspension of magnesium hydroxide (milk of magnesia). The target pH for each treatment will be determined from the results of a pilot study. Each dose administration will be separated by at least seven days. Study subjects will participate in a total of five study visits.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol Delta(9)-tetrahydrocannabinol

Medicines

SATIVEX

Interventions

What was registered

DRUG

Sativex

Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivers 2.7 mg THC and 2.5 mg CBD.

Nabiximols · THC/CBD spray

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepted

Inclusion criteria

Subject is willing and able to give informed consent for participation in the study;
Male and/or female subjects aged 18 to 50 years, inclusive;
Subject must weigh at least 50.0 kg and have a body mass index (BMI) between 19.0 and 35.0 kg/m2, inclusive;
Subject must be a non-smoker for at least three months prior to screening and must be willing to abstain from smoking during the study;
Subject must be in good health as determined by the investigator from medical history, physical and oral examination findings, 12-lead standard ECG findings and clinical laboratory test results (laboratory results outside of the reference range must be documented as acceptable by both the investigator and sponsor);
Subject is able (in the investigator's opinion) and willing to comply with all study requirements;
Subject is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion criteria

Use of any prescription medications or herbal supplements within 2 weeks prior to Day 1 of the first treatment visit or any over the counter medications or supplements within 72 hours prior to first study medication administration;
Subject has oral issues/condition likely, in the opinion of the investigator, to affect the assessment of the oromucosal absorption of Sativex;
Subject is physically dependent on alcohol, has a history of drug or alcohol abuse within the 12 months prior to dose administration or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations;
Subject has a positive result for the presence of hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCAb) or human immunodeficiency virus (HIV) antibodies;
Subject is currently using or has used cannabis, cannabinoid-based medications (e.g. Marinol®, Nabilone®, Cannador®) or Acomplia (rimonabant) or taranabant within 30 days of study entry (first treatment visit) and is unwilling to abstain for the duration of the study;
Subject consumes more than five caffeinated beverages per day (e.g., five cups of tea or coffee or cans of cola) or is unwilling to abstain from consumption of caffeine-containing food and beverages throughout the study period;

primary outcomes