Study to Determine the Effects of Multiple-dose Omeprazole on the Single-dose Pharmacokinetics of Tipranavir (TPV) Coadministered With Ritonavir (RTV) in Healthy Adult Volunteers

Inclusion criteria

• Male and female healthy volunteers between 18 and 60 years of age inclusive
• Clinically normal medical history
• Clinically normal findings on physical examination
• Clinically normal laboratory values
• Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive
• Ability to swallow large capsules without difficulty
• Capable of comprehending and communicating effectively with the investigator and site staff
• Signed and dated written informed consent form, in accordance with Ethics Committee and regulatory guidelines prior to trial participation
• Willingness to abstain from ingesting substances which may alter plasma drug levels by interactions with the cytochrome P450 system during the 14 days of the study
• Willingness to abstain from alcohol for 48 hours prior to Visit 2 and for the duration of the study
• Willingness to abstain from ingesting grapefruit and grapefruit juice for 7 days before Visit 2 and for the duration of the study
• Negative pregnancy test (β-hCG)
• Negative HIV serology
• Negative hepatitis serology

Exclusion criteria

• Any clinically significant disease (a significant disease is defined as a disease, which in the opinion of the investigator may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study or the subject's ability to participate in the study)
• Clinically significant abnormal baseline hematology, blood chemistry or urinalysis findings normal at Visit 2
• Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), cholesterol, triglyceride or glucose greater than the upper limit of normal at Visit 2
• Treatment with any investigational drug within 90 days prior to the first dose of study medication
• Inability to adhere to the requirements of the protocol as assessed by the investigator
• Prior TPV use
• Subjects who are taking or have taken medications metabolized through the Cytochrome P-450 (CYP450) enzyme system within 30 days prior to Visit 2
• Subject with a seated systolic blood pressure either <100 mmHg or >150 mmHg; resting heart rate either <50 beats/min or >100 beats/min
• Subject with a history of any illness or allergy that in the investigator opinion might confound the results of the study, or pose additional risk to the subject with the administering of TPV/r or omeprazole
• Subject who have had an acute illness within 14 days prior to Visit 2
• Subject who are currently taking or have taken over-the-counter medications in the 14 days prior to Visit 2, or subjects who are currently taking any prescription medication
• Known hypersensitivity to TPV, RTV, omeprazole or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
• Female subjects who are of reproductive potential and who are:

• Pregnant or breast-feeding
• Have a positive serum β-hCG (pregnancy test) at screening visit (Visit 1)
• Have not been using a barrier contraceptive method for at least 60 days prior to Study Day 1
• Are not willing to use a reliable method of double-barrier contraception during the trial and for 30 days after completion or termination of the trial