NCT01887301

Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients

An Open Label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics and Tolerability of a Single Oromucosal Dose of 4 Sprays of Sativex(Containing 10.8 mg Delta-9-tetrahydrocannabinol [THC] and 10 mg Cannabidiol [CBD]) in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) in healthy patients and those with hepatic (liver) function impairment.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Sativex	Patients receive four sprays (each 100 uL) of Sativex to the oral mucosa, which contain 10.8 mg THC and 10 mg CBD in total.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-06-26
• Last updated: 2022-12-20

Locations

2 sites across 1 country: United States