NCT01323465 - Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions

Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor

Interventions

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.

Trial Locations (1)

SE1 1YR

Guy's Drug Research Unit, Quintiles Ltd., London