TMC278-TiDP6-C154: Evaluation of the Possible Influence of Omeprazole Intake - and the pH Increase in the Stomach Triggered by Omeprazole Intake - on the Blood Levels of TMC278 in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-04-01

Summary

The purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d.. This study also investigates - in case levels of TMC278 are reduced when co-administered with omeprazole - whether a double dose of TMC278 (50 mg q.d.) or a separation of intake of both drugs by 12 hours may circumvent a decrease of TMC278 levels in the blood below the clinical effective concentration. Omeprazole is prescribed to reduce the production of gastric acid. Since TMC278 requires gastric acid to be properly dissolved and taken up in the blood circulation, intake of omeprazole has an influence on the levels of TMC278 in the blood circulation. This effect has been revealed in a previously conducted clinical trial, using the combination of 150 mg TMC278 q.d. and 20 mg q.d. omeprazole. The currently proposed study will also further explore the relationship between the levels of TMC278 in the blood at several time points and the acidity of the stomach. Also the short-term safety and tolerability of co-administration of omeprazole 20 mg q.d. and TMC278 25 mg q.d. will be assessed.

• Phase: Phase 1

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Omeprazole; Rilpivirine