Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT02240160
Status:
TERMINATED
Last Update Posted:
2021-02-05
First Post:
2014-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
GW Pharmaceuticals Ltd
Organization:
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2021-02
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:
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).
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).
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-004459-19 | EUDRACT_NUMBER | None | View |