An Open-label Clinical Trial to Compare the Pharmacokinetics of up to 4 Single Oromucosal Doses of 4 Sprays of Sativex® in Patients With Treatment Induced Mild, Moderate and Severe Oral Mucositis (Grade 1 - 3 RTOG Oral Mucositis) With Their Pharmacokinetic Profile Pre-treatment (When Mucositis-free)

NCT01975688 Phase 1 TERMINATED

To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics \[PKs\] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) when mild, moderate or severe oral mucositis is induced. This will be done by looking at the effects of the body on the drug before and after oral mucositis is induced. The study participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral mucositis will be induced with radiotherapy and/or chemotherapy.

Details

Lead sponsor	GW Pharmaceuticals Ltd
Phase	Phase 1
Status	TERMINATED
Enrolment	10
Start date	2014-02
Completion	2015-06

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

• Sativex

Primary outcomes

• The time to peak plasma concentration (Cmax) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex — Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
  Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
• Area under the concentration-time curve from administration until the last sampling point (t) equal or above the Lower Limit of Quantification (AUC(0-t)) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex — Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
  Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).
• Area under the concentration-time curve extrapolated to infinity (AUC(0-∞)) of THC, 11-hydroxy-THC, CBD, 7-hydroxy-CBD and 6-hydroxy-CBD after a single dose of Sativex — Pre-dose then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose
  Blood samples for PK analysis were taken at pre-defined time-points by either direct venipuncture or an indwelling cannula inserted in a forearm vein. Blood was drawn from each subject into a five-mL lithium-heparinised tube. The allowable window for sample collection was ±5 minutes at all PK time points with the exception of 8 hours (window of ±1 hour) and 24 hours (±2 hours).

Countries

United Kingdom