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
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Tipranavir (TPV) (Drug); Ritonavir (Drug); Omeprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
Study to determine the effects of multiple-dose omeprazole on the single-dose
pharmacokinetics of tipranavir and ritonavir
Clinical Details
Official title: A Single-centre, Open-label Study in Healthy Adult Volunteers to Determine the Effects of Multiple-dose Omeprazole (ANTRA® 40 mg qd) on the Single-dose Pharmacokinetics of Tipranavir 500 mg Coadministered With Ritonavir 200 mg
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cmax (Maximum plasma concentration of Tipranavir in plasma)AUC0-72h (Area Under Plasma Concentration-time curve of Tipranavir from 0-72 hr)
Secondary outcome: Cmax (Maximum plasma concentration of Ritonavir in plasma)AUC0-72h (Area Under Plasma Concentration-time curve of Ritonavir from 0-72 hr) AUC0-∞ (Area Under Plasma Concentration-time curve from 0 to infinity) MRT (Mean residence time) t1/2 (apparent terminal halflife) Tmax (Time to maximum concentration of the analyte in plasma) CL/F (Oral clearance) Vz/F (Apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor) Number of subjects with adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and female healthy volunteers between 18 and 60 years of age inclusive
2. Clinically normal medical history
3. Clinically normal findings on physical examination
4. Clinically normal laboratory values
5. Body Mass Index (BMI) between 18. 5 and 30 kg/m2 inclusive
6. Ability to swallow large capsules without difficulty
7. Capable of comprehending and communicating effectively with the investigator and site
staff
8. Signed and dated written informed consent form, in accordance with Ethics Committee
and regulatory guidelines prior to trial participation
9. 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
10. Willingness to abstain from alcohol for 48 hours prior to Visit 2 and for the
duration of the study
11. Willingness to abstain from ingesting grapefruit and grapefruit juice for 7 days
before Visit 2 and for the duration of the study
12. Negative pregnancy test (β-hCG)
13. Negative HIV serology
14. Negative hepatitis serology
Exclusion Criteria:
1. 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)
2. Clinically significant abnormal baseline hematology, blood chemistry or urinalysis
findings normal at Visit 2
3. Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), cholesterol,
triglyceride or glucose greater than the upper limit of normal at Visit 2
4. Treatment with any investigational drug within 90 days prior to the first dose of
study medication
5. Inability to adhere to the requirements of the protocol as assessed by the
investigator
6. Prior TPV use
7. Subjects who are taking or have taken medications metabolized through the Cytochrome
P-450 (CYP450) enzyme system within 30 days prior to Visit 2
8. Subject with a seated systolic blood pressure either <100 mmHg or >150 mmHg; resting
heart rate either <50 beats/min or >100 beats/min
9. 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
10. Subject who have had an acute illness within 14 days prior to Visit 2
11. 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
12. Known hypersensitivity to TPV, RTV, omeprazole or antiretroviral drugs (marketed or
experimental use as part of clinical research studies)
13. 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
Locations and Contacts
Additional Information
Starting date: November 2005
Last updated: September 30, 2014
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