Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Study to determine the effects of multiple-dose omeprazole on the single-dose pharmacokinetics of tipranavir and ritonavir
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02253875
Start Date
November 1 2005
Last Update
October 1 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.