Healthy VolunteersPhase 1NCT00936871
The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
A Phase 1 study testing Lersivirine, Lersivirine (if necessary) and Moxifloxacin in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
Trial summary
This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine. 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?
- Lersivirine, Lersivirine (if necessary) and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to Mar 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive, (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, normal 12-lead ECG and clinical laboratory tests)
Who cannot join
- History of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction).
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
- Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Single Dose, Placebo And Active Controlled, 3-Way Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.
- Conditions
- Healthy Volunteers
- Being tested
- Lersivirine, Placebo, Lersivirine (if necessary), Moxifloxacin
- Keywords
- lersivirine QT QTc ECG HIV NNRTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LersivirineDrug
Lersivirine 2400 mg single dose
PlaceboDrug
Placebo single dose
Lersivirine (if necessary)Drug
Lersivirine 2100 mg single dose (if necessary)
LersivirineDrug
Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)
PlaceboDrug
Placebo single dose
MoxifloxacinDrug
Moxifloxacin 400 mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Lersivirine Tolerability Receives: Drug: Lersivirine; Drug: Placebo; Drug: Lersivirine (if necessary) |
| Part B | Experimental | Thorough QTc Receives: Drug: Lersivirine; Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
Measured: 1 day
(Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.
Measured: 3 days
Secondary outcomes (4)
To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours.
Measured: 1 day
To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
Measured: 1 day
To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.
Measured: 1 day
To assess the single dose pharmacokinetics of lersivirine.
Measured: 1 - 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
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
- NCT00936871
- Sponsor's protocol ID
- A5271032
- Status last verified
- Sep 2010
- First submitted
- 7 Jul 2009
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single Dose, Placebo And Active Controlled, 3-Way Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00936871
- Acronym / sponsor ID
- A5271032
- Conditions
- Healthy Volunteers
- Keywords
- lersivirine QT QTc ECG HIV NNRTI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Jul 2009 (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.
This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Lersivirine, Drug: Placebo, Drug: Lersivirine (if necessary)Lersivirine Tolerability |
| Part B | Experimental | Drug: Lersivirine, Drug: Placebo, Drug: MoxifloxacinThorough QTc |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive, (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, normal 12-lead ECG and clinical laboratory tests)
Key exclusion criteria (3 listed)
- History of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction).
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
- Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
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 |
|---|---|---|
| LersivirineLersivirine 2400 mg single dose | Drug | Part A |
| PlaceboPlacebo single dose | Drug | Part A |
| Lersivirine (if necessary)Lersivirine 2100 mg single dose (if necessary) | Drug | Part A |
| LersivirineLersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results) | Drug | Part B |
| PlaceboPlacebo single dose | Drug | Part B |
| MoxifloxacinMoxifloxacin 400 mg single dose | Drug | Part B |
Primary outcome
(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
Time frame: 1 day
(Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.
Time frame: 3 days
4 secondary outcomes
To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours.
Time frame: 1 day
To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
Time frame: 1 day
To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.
Time frame: 1 day
To assess the single dose pharmacokinetics of lersivirine.
Time frame: 1 - 2 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 6 Sep 2010.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lersivirine, Lersivirine (if necessary) and Moxifloxacin in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
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 3 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 6 Sep 2010. 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 Belgium. 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 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?
(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects. (time frame: 1 day). 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 6 Sep 2010.