Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine 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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-01-31

Brief Summary

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This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.

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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

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abacavir/Lamivudine

Group Type ACTIVE_COMPARATOR

Abacavir/Lamivudine

Intervention Type DRUG

Abacavir/Lamivudine 600/300 mg QD for 5 days

Lersivirine + Abacavir/Lamivudine

Group Type EXPERIMENTAL

Abacavir/Lamivudine

Intervention Type DRUG

Abacavir/Lamivudine 600/300 mg QD for 10 days

Lersivirine

Intervention Type DRUG

Lersivirine 750 mg QD for 10 days

Interventions

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Abacavir/Lamivudine

Abacavir/Lamivudine 600/300 mg QD for 5 days

Intervention Type DRUG

Abacavir/Lamivudine

Abacavir/Lamivudine 600/300 mg QD for 10 days

Intervention Type DRUG

Lersivirine

Lersivirine 750 mg QD for 10 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.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria

* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* History of hypersensitivity to abacavir, lamivudine and/or lersivirine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes