Healthy VolunteersPhase 1NCT01230385
Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
A Phase 1 study testing Lersivirine in people with Healthy Volunteers, run by Pfizer at 2 sites in 2 countries.
Trial summary
Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2010to May 2011
- 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.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: Randomized, Open-Label, Parallel Group Study To Investigate The Safety And Tolerability Of Multiple Dose Lersivirine (Proposed Phase 3 Formulation) For 21 Days In Healthy Subjects
Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.
- Conditions
- Healthy Volunteers
- Being tested
- Lersivirine
- Keywords
- lersivirine, UK-453, 061, safety, tolerability, pharmacokinetics, HIV, non-nucleoside reverse transcriptase inhibitor, NNRTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LersivirineDrug
Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days
LersivirineDrug
Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days
LersivirineDrug
Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days
LersivirineDrug
Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days
LersivirineDrug
Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Lersivirine 500 mg QD fasted (wet granulated tablet) | Experimental | Not described Receives: Drug: Lersivirine |
| Lersivirine 500 mg QD fed (wet granulated tablet) | Experimental | Not described Receives: Drug: Lersivirine |
| Lersivirine 750 mg QD fasted (wet granulated tablet) | Experimental | Not described Receives: Drug: Lersivirine |
| Lersivirine 750 mg QD fed (wet granulated tablet) | Experimental | Not described Receives: Drug: Lersivirine |
| Lersivirine 500 mg QD fasted (dry granulated tablet) | Active comparator | Not described Receives: Drug: Lersivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days.
Measured: 21 days
Secondary outcomes (1)
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionMay 2011
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230385
- Sponsor's protocol ID
- A5271049
- Status last verified
- May 2011
- First submitted
- 8 Oct 2010
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Parallel Group Study To Investigate The Safety And Tolerability Of Multiple Dose Lersivirine (Proposed Phase 3 Formulation) For 21 Days In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01230385
- Acronym / sponsor ID
- A5271049
- Conditions
- Healthy Volunteers
- Keywords
- lersivirine, UK-453, 061, safety, tolerability, pharmacokinetics, HIV, non-nucleoside reverse transcriptase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Oct 2010 (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.
Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lersivirine 500 mg QD fasted (wet granulated tablet) | Experimental | Drug: Lersivirine |
| Lersivirine 500 mg QD fed (wet granulated tablet) | Experimental | Drug: Lersivirine |
| Lersivirine 750 mg QD fasted (wet granulated tablet) | Experimental | Drug: Lersivirine |
| Lersivirine 750 mg QD fed (wet granulated tablet) | Experimental | Drug: Lersivirine |
| Lersivirine 500 mg QD fasted (dry granulated tablet) | Active comparator | Drug: Lersivirine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (3 listed)
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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 500 mg QD fasted (wet granulated tablet) for 21 days | Drug | Lersivirine 500 mg QD fasted (wet granulated tablet) |
| LersivirineLersivirine 500 mg QD fed (wet granulated tablet) for 21 days | Drug | Lersivirine 500 mg QD fed (wet granulated tablet) |
| LersivirineLersivirine 750 mg QD fasted (wet granulated tablet) for 21 days | Drug | Lersivirine 750 mg QD fasted (wet granulated tablet) |
| LersivirineLersivirine 750 mg QD fed (wet granulated tablet) for 21 days | Drug | Lersivirine 750 mg QD fed (wet granulated tablet) |
| LersivirineLersivirine 500 mg QD fasted (dry granulated tablet) for 21 days | Drug | Lersivirine 500 mg QD fasted (dry granulated tablet) |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days.
Time frame: 21 days
1 secondary outcome
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7
Time frame: 21 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 17 May 2011.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lersivirine in people with Healthy Volunteers, run by Pfizer at 2 sites in 2 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 3 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 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days. (time frame: 21 days). 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 17 May 2011.