NCT03201835

5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers

A Single-Center, Randomized, 5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: PhytoTech Therapeutics, Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study was to evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray.

Detailed description

Fifteen (15) healthy male volunteers received, following an overnight fasting and a standard breakfast, a single dose of either one of five administrations: PNL-THC:CBD, P-PNL-THC:CBD, CBD10 hard capsule, CBD100 hard capsule, Sativex® spray X 4. There was a wash-out period of no less than 4 days between each dosing. Subjects underwent screening procedures within 21 days prior to first dosing, to assess their eligibility to participate in the study. Eligible subjects were admitted to the Clinical Research Center (CRC) in the evening before each study drug administration and will remained in-house for 24 hours after dosing. Following an overnight fast of at least 10 hours, the subjects received a standard meal within 30 minutes prior to dosing. Blood samples for PK were drawn at the specified time points. The subjects were monitored for safety, and AEs were recorded throughout the study. An End-of Study (EOS)/Safety Follow-up visit took place on 7-10 days after the last dose of study treatment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PNL-THC:CBD soft gelatin capsule	3 soft capsules, containing a total of 10.8 mg THC and 10 mg CBD (Each capsule contains 3.6 mg THC and 3.3 mg CBD)
DRUG	Sativex	spray X 4 actuations
DRUG	CBD hard capsule dose 1	1 hard capsule containing 10 mg CBD
DRUG	P-PNL-THC:CBD soft gelatin capsule	2 soft capsules containing a total of 7.2 mg THC, 6.7 mg CBD and 20 mg piperine (Each capsule contains 3.6 mg THC, 3.3 mg CBD and 10 mg piperine)
DRUG	CBD hard capsule dose 2	1 hard capsule containing 100 mg CBD

Timeline

• Start date: 2015-09-24
• Primary completion: 2015-12-06
• Completion: 2016-06-06
• First posted: 2017-06-28
• Last updated: 2017-09-20

Locations

1 site across 1 country: Israel