Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2025-12-24 @ 10:43 PM
Study NCT ID:
NCT03201835
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2017-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
PhytoTech Therapeutics, Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: