- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02253875
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
September 30, 2014 updated by: Boehringer Ingelheim
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 to determine the effects of multiple-dose omeprazole on the single-dose pharmacokinetics of tipranavir and ritonavir
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TPV + RTV + Omeprazole
|
Other Names:
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax (Maximum plasma concentration of Tipranavir in plasma)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
AUC0-72h (Area Under Plasma Concentration-time curve of Tipranavir from 0-72 hr)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with adverse events
Time Frame: up to 24 days
|
up to 24 days
|
Cmax (Maximum plasma concentration of Ritonavir in plasma)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
AUC0-72h (Area Under Plasma Concentration-time curve of Ritonavir from 0-72 hr)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
AUC0-∞ (Area Under Plasma Concentration-time curve from 0 to infinity)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
MRT (Mean residence time)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
t1/2 (apparent terminal halflife)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
Tmax (Time to maximum concentration of the analyte in plasma)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
CL/F (Oral clearance)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
Vz/F (Apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor)
Time Frame: up to 72 hours after drug administration
|
up to 72 hours after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
September 30, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Estimate)
October 1, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Gastrointestinal Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Tipranavir
- Omeprazole
Other Study ID Numbers
- 1182.84
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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