MedDataX Logo

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

NCT ID: NCT01603485

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bioavailability Pharmacokinetics Lersivirine Modified-release

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lersivirine

Group Type EXPERIMENTAL

Lersivirine Immediate-Release (fasted)

Intervention Type DRUG

Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)

Lersivirine Modified-Release #1 (fasted)

Intervention Type DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet #1

Lersivirine Modified-Release #2 (fasted)

Intervention Type DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet #2

Lersivirine Modified-Release #3 (fasted)

Intervention Type DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet #3

Lersivirine Modified-Release (fed)

Intervention Type DRUG

Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lersivirine Immediate-Release (fasted)

Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)

Intervention Type DRUG

Lersivirine Modified-Release #1 (fasted)

Single 500 mg dose of Lersivirine Modified-Release Tablet #1

Intervention Type DRUG

Lersivirine Modified-Release #2 (fasted)

Single 500 mg dose of Lersivirine Modified-Release Tablet #2

Intervention Type DRUG

Lersivirine Modified-Release #3 (fasted)

Single 500 mg dose of Lersivirine Modified-Release Tablet #3

Intervention Type DRUG

Lersivirine Modified-Release (fed)

Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271050&StudyName=Study%20to%20Estimate%20the%20Pharmacokinetics%2C%20Bioavailability%20and%20Effect%20of%20Food%20on%20Single%20Dose%20Modified-release%20Lersivirine%20500%20mg%20in%20Healthy

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A5271050

Identifier Type: -

Identifier Source: org_study_id