Healthy VolunteerPhase 1NCT01603485

Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects

A Phase 1 study testing Lersivirine Immediate-Release (fasted), Lersivirine Modified-Release #1 (fasted) and Lersivirine Modified-Release #2 (fasted) in people with Healthy Volunteer, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Lersivirine Immediate-Release (fasted), Lersivirine Modified-Release #1 (fasted) and Lersivirine Modified-Release #2 (fasted)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteBelgium
Study dates: Jun 2012to Aug 2012
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

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

History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening;
Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication;
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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Investigational Site
Brussels, B-1070

Other trials in Belgium

About this study

Official title: Open-Label, Randomized, Crossover Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-Release Lersivirine (UK-453,061) 500 mg in Healthy Subjects

The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different modified-release formulations of lersivirine and compare it to the PK of the immediate-release tablet. The effect of food on the PK of one of the modified-release tablets will also be assess along with the safety and tolerability of each treatment.

Conditions: Healthy Volunteer
Being tested: Lersivirine Immediate-Release (fasted), Lersivirine Modified-Release #1 (fasted), Lersivirine Modified-Release #2 (fasted), Lersivirine Modified-Release #3 (fasted), Lersivirine Modified-Release (fed)
Keywords: Bioavailability, Pharmacokinetics, Lersivirine, Modified-release

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lersivirine Immediate-Release (fasted)Drug
Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)
Lersivirine Modified-Release #1 (fasted)Drug
Single 500 mg dose of Lersivirine Modified-Release Tablet #1
Lersivirine Modified-Release #2 (fasted)Drug
Single 500 mg dose of Lersivirine Modified-Release Tablet #2
Lersivirine Modified-Release #3 (fasted)Drug
Single 500 mg dose of Lersivirine Modified-Release Tablet #3
Lersivirine Modified-Release (fed)Drug
Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.

Study groups in NCT01603485
Study group	Role	What they receive
Lersivirine	Experimental	Not described Receives: Drug: Lersivirine Immediate-Release (fasted); Drug: Lersivirine Modified-Release #1 (fasted); Drug: Lersivirine Modified-Release #2 (fasted); Drug: Lersivirine Modified-Release #3 (fasted); Drug: Lersivirine Modified-Release (fed)

What is being measured

The primary outcome is the main question the study is designed to answer.

Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Measured: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Maximum Observed Plasma Concentration (Cmax)
Measured: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose

Secondary outcomes (4)

Lersivirine Plasma Decay Half-Life (t1/2)
Measured: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Observed Plasma Concentration at time 24hr (C24)
Measured: T = 24 hours post dose
Lersivirine Last Observed Plasma Concentration (Clast)
Measured: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Aug 2012

First posted22 May 2012 (estimated)
Study startJun 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01603485
Sponsor's protocol ID: A5271050
Status last verified: Sep 2012
First submitted: 10 May 2012
Last updated: 19 Sep 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, Randomized, Crossover Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-Release Lersivirine (UK-453,061) 500 mg in Healthy Subjects
ClinicalTrials.gov ID: NCT01603485
Acronym / sponsor ID: A5271050
Conditions: Healthy Volunteer
Keywords: Bioavailability, Pharmacokinetics, Lersivirine, Modified-release
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: ViiV Healthcare
Study start: Jun 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 22 May 2012 (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 design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lersivirine	Experimental	Drug: Lersivirine Immediate-Release (fasted), Drug: Lersivirine Modified-Release #1 (fasted), Drug: Lersivirine Modified-Release #2 (fasted), Drug: Lersivirine Modified-Release #3 (fasted), Drug: Lersivirine Modified-Release (fed)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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)

History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening;
Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication;
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.

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
Lersivirine Immediate-Release (fasted)Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)	Drug	Lersivirine
Lersivirine Modified-Release #1 (fasted)Single 500 mg dose of Lersivirine Modified-Release Tablet #1	Drug	Lersivirine
Lersivirine Modified-Release #2 (fasted)Single 500 mg dose of Lersivirine Modified-Release Tablet #2	Drug	Lersivirine
Lersivirine Modified-Release #3 (fasted)Single 500 mg dose of Lersivirine Modified-Release Tablet #3	Drug	Lersivirine
Lersivirine Modified-Release (fed)Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.	Drug	Lersivirine

Primary outcome

Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Maximum Observed Plasma Concentration (Cmax)
Time frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose

4 secondary outcomes

Lersivirine Plasma Decay Half-Life (t1/2)
Time frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Observed Plasma Concentration at time 24hr (C24)
Time frame: T = 24 hours post dose
Lersivirine Last Observed Plasma Concentration (Clast)
Time frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose

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 19 Sep 2012.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

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?

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 2 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 19 Sep 2012. 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?

Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (time frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603485.

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 19 Sep 2012.