HealthyPhase 1NCT02253875
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
A Phase 1 study testing Tipranavir (TPV), Ritonavir and Omeprazole in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the effects of multiple-dose omeprazole on the single-dose pharmacokinetics of tipranavir and ritonavir Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tipranavir (TPV), Ritonavir and Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Feb 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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 to determine the effects of multiple-dose omeprazole on the single-dose pharmacokinetics of tipranavir and ritonavir
- Conditions
- Healthy
- Being tested
- Tipranavir (TPV), Ritonavir, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipranavir (TPV)Drug
Also called (Aptivus ®)
RitonavirDrug
Also called (Norvir-SEC®)
OmeprazoleDrug
Also called (Antra®)
| Study group | Role | What they receive |
|---|---|---|
| TPV + RTV + Omeprazole | Experimental | Not described Receives: Drug: Tipranavir (TPV); Drug: Ritonavir; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum plasma concentration of Tipranavir in plasma)
Measured: up to 72 hours after drug administration
AUC0-72h (Area Under Plasma Concentration-time curve of Tipranavir from 0-72 hr)
Measured: up to 72 hours after drug administration
Secondary outcomes (9)
Cmax (Maximum plasma concentration of Ritonavir in plasma)
Measured: up to 72 hours after drug administration
AUC0-72h (Area Under Plasma Concentration-time curve of Ritonavir from 0-72 hr)
Measured: up to 72 hours after drug administration
AUC0-∞ (Area Under Plasma Concentration-time curve from 0 to infinity)
Measured: up to 72 hours after drug administration
MRT (Mean residence time)
Measured: up to 72 hours after drug administration
t1/2 (apparent terminal halflife)
Measured: up to 72 hours after drug administration
Tmax (Time to maximum concentration of the analyte in plasma)
Measured: up to 72 hours after drug administration
CL/F (Oral clearance)
Measured: up to 72 hours after drug administration
Vz/F (Apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor)
Measured: up to 72 hours after drug administration
Number of subjects with adverse events
Measured: up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startNov 2005
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253875
- Sponsor's protocol ID
- 1182.84
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02253875
- Acronym / sponsor ID
- 1182.84
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2006 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the effects of multiple-dose omeprazole on the single-dose pharmacokinetics of tipranavir and ritonavir
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPV + RTV + Omeprazole | Experimental | Drug: Tipranavir (TPV), Drug: Ritonavir, Drug: Omeprazole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tipranavir (TPV)Also: (Aptivus ®) | Drug | TPV + RTV + Omeprazole |
| RitonavirAlso: (Norvir-SEC®) | Drug | TPV + RTV + Omeprazole |
| OmeprazoleAlso: (Antra®) | Drug | TPV + RTV + Omeprazole |
Primary outcome
Cmax (Maximum plasma concentration of Tipranavir in plasma)
Time frame: 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
9 secondary outcomes
Cmax (Maximum plasma concentration of Ritonavir in plasma)
Time frame: 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
AUC0-∞ (Area Under Plasma Concentration-time curve from 0 to infinity)
Time frame: up to 72 hours after drug administration
MRT (Mean residence time)
Time frame: up to 72 hours after drug administration
t1/2 (apparent terminal halflife)
Time frame: 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
CL/F (Oral clearance)
Time frame: 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
Number of subjects with adverse events
Time frame: up to 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tipranavir (TPV), Ritonavir and Omeprazole in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (Maximum plasma concentration of Tipranavir in plasma) (time frame: up to 72 hours after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.