Healthy VolunteersPhase 4NCT00312182
Thorough QT Study of Nelfinavir
A Phase 4 study testing Nelfinavir in people with Healthy Volunteers, run by Pfizer at 4 sites in 3 countries.
Trial summary
To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation 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
- How many people
- 68 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Mar 2006to Jun 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 and female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48105
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473
About this study
Official title: Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers
To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation
- Conditions
- Healthy Volunteers
- Being tested
- Nelfinavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelfinavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG evaluation
Secondary outcomes (1)
Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startMar 2006
- Study completionJun 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312182
- Sponsor's protocol ID
- A4301023
- Status last verified
- Apr 2009
- First submitted
- 5 Apr 2006
- Last updated
- 10 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00312182
- Acronym / sponsor ID
- A4301023
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 7 Apr 2006 (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 assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant 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 | Drug | – |
Primary outcome
ECG evaluation
1 secondary outcome
Pharmacokinetics
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 10 Apr 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nelfinavir in people with Healthy Volunteers, run by Pfizer at 4 sites in 3 countries.
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 10 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium, Singapore. 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?
ECG evaluation. 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 10 Apr 2009.