NCT01323465

Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex

A Phase I, Open-label, Randomised, Crossover Study in 3 Parallel Groups to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics of a single dose of Sativex and to evaluate the safety of Sativex when given in combination with these other drugs.

Detailed description

An open-label, randomised, crossover, drug interaction study. Subjects were divided into three groups and within each group, subjects were randomised to one of two treatment sequences. Subjects received 4 sprays of Sativex alongside either doses of rifampicin, ketoconazole or omeprazole.

Conditions

• Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4
• Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4
• Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor

Interventions

Type	Name	Description
DRUG	Sativex and rifampicin	Single dose of 4 sprays Sativex on Day 1, Rifampicin 2 x 300 mg capsules on Days 2-10, Sativex dose of 4 sprays and rifampicin 2 x 300 mg capsules on Day 11.
DRUG	Sativex and rifampicin	Rifampicin 2 x 300 mg capsules on Days 1-9, Sativex x 4 sprays and rifampicin 2 x 300 mg capsules on Day 10, Single dose of Sativex 4 sprays on Day 18.
DRUG	Sativex and ketoconazole	Single dose of 4 sprays Sativex on Day 1, ketoconazole 2 x 200 mg tablets on Days 2-5, Sativex x 4 sprays and ketoconazole 2 x 200mg on Day 6.
DRUG	Sativex and ketoconazole	Ketoconazole 2 x 200 mg tablets on Days 1-4, Sativex x 4 sprays and ketoconazole 2 x 200 mg tablets on Day 5, Single dose of 4 sprays Sativex on Day 9.
DRUG	Sativex and omeprazole	Single dose of 4 sprays of Sativex on Day 1 Omeprazole 2 x 20 mg on Days 2-6. Sativex x 4 sprays and omeprazole 2 x 20 mg on Day 9.
DRUG	Sativex and omeprazole	Omeprazole 2 x 20 mg on Days 1-5, Sativex x 4 sprays and omeprazole 2 x 20 mg on Day 6, Single dose of 4 sprays Sativex on Day 9.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2011-03-25
• Last updated: 2023-04-10

Locations

1 site across 1 country: United Kingdom