Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lersivirine 500 mg QD fasted (wet granulated tablet)

Group Type EXPERIMENTAL

Lersivirine

Intervention Type DRUG

Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days

Lersivirine 500 mg QD fed (wet granulated tablet)

Group Type EXPERIMENTAL

Lersivirine

Intervention Type DRUG

Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days

Lersivirine 750 mg QD fasted (wet granulated tablet)

Group Type EXPERIMENTAL

Lersivirine

Intervention Type DRUG

Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days

Lersivirine 750 mg QD fed (wet granulated tablet)

Group Type EXPERIMENTAL

Lersivirine

Intervention Type DRUG

Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days

Lersivirine 500 mg QD fasted (dry granulated tablet)

Group Type ACTIVE_COMPARATOR

Lersivirine

Intervention Type DRUG

Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days

Interventions

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Lersivirine

Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days

Intervention Type DRUG

Lersivirine

Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days

Intervention Type DRUG

Lersivirine

Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days

Intervention Type DRUG

Lersivirine

Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days

Intervention Type DRUG

Lersivirine

Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes