The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects

A Phase 1, Randomized, Single Dose, Placebo And Active Controlled, 3-Way Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00936871

Enrollment

Registered

2009-07-10

Start date

2010-01-31

Completion date

2010-03-31

Last updated

2010-09-06

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

Conditions

Healthy Volunteers

Keywords

lersivirine QT QTc ECG HIV NNRTI

Brief summary

This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.

Interventions

DRUGLersivirine (if necessary)

Lersivirine 2100 mg single dose (if necessary)

DRUGLersivirine

Lersivirine 2400 mg single dose

DRUGPlacebo

Placebo single dose

DRUGMoxifloxacin

Moxifloxacin 400 mg single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive, (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, normal 12-lead ECG and clinical laboratory tests)

Exclusion criteria

* History of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction). * Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day * Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication.

Design outcomes

Primary

Measure	Time frame
(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.	1 day
(Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.	3 days

Secondary

Measure	Time frame
To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours.	1 day
To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.	1 day
To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.	1 day
To assess the single dose pharmacokinetics of lersivirine.	1 - 2 days

Countries

Belgium

Outcome results

None listed

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