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

NCT01603485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-09-19

No results posted yet for this study

Summary

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

Interventions

DRUG

Lersivirine Immediate-Release (fasted)

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

DRUG

Lersivirine Modified-Release #1 (fasted)

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

DRUG

Lersivirine Modified-Release #2 (fasted)

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

DRUG

Lersivirine Modified-Release #3 (fasted)

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

DRUG

Lersivirine Modified-Release (fed)

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

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01603485 on ClinicalTrials.gov