Healthy VolunteersPhase 4NCT00251030
A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
A Phase 4 study testing Nelfinavir and Omeprazole in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nelfinavir and Omeprazole
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2006
- Phase
- Phase 4
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects between the ages of 18 and 55 years.
Who cannot join
- Subjects with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
About this study
To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects
- Conditions
- Healthy Volunteers
- Being tested
- Nelfinavir and Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfinavir and OmeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects
Secondary outcomes (1)
To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startNov 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jasper Clinic, Michigan
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251030
- Sponsor's protocol ID
- A4301024
- Status last verified
- Feb 2009
- First submitted
- 8 Nov 2005
- Last updated
- 16 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00251030
- Acronym / sponsor ID
- A4301024
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Jasper Clinic, Michigan
- Study start
- Nov 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 9 Nov 2005 (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.
To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female subjects between the ages of 18 and 55 years.
Key exclusion criteria (1 listed)
- Subjects with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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 |
|---|---|---|
| Nelfinavir and Omeprazole | Drug | – |
Primary outcome
To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects
1 secondary outcome
To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole
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 16 Feb 2009.
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Screening Protocol
Pain
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nelfinavir and Omeprazole in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
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 1 inclusion and 1 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 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects. 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 16 Feb 2009.