Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01220232

Enrollment

Registered

2010-10-13

Start date

2010-11-30

Completion date

2011-01-31

Last updated

2011-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Lersivirine, UK-453, 061, NNRTI, Abacavir, Lamivudine, Combivir, Pharmacokinetics, Drug Interaction, HIV, AIDS

Brief summary

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.

Interventions

DRUGAbacavir/Lamivudine

Abacavir/Lamivudine 600/300 mg QD for 5 days

DRUGLersivirine

Lersivirine 750 mg QD for 10 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.	17 days

Secondary

Measure	Time frame
To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.	17 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026