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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection

• Weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included

• Informed Consent Form (ICF) signed voluntarily

• Able to comply with protocol requirements

• Healthy on the basis of a pretrial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG)

Exclusion Criteria:

• No positive testing for HIV-1 or -2

• females, except if menopausal for at least 2 years, or with total hysterectomy or bilateral tubal ligation (without repair surgery)

• No infection of Hepatitis A, B or C

• No currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease

• No history of clinically relevant heart rhythm disturbances

• No positive urine drug testing