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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00936871

Collaborator

(none)

Enrollment

Location

Arms

1.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Lersivirine Drug: Placebo Drug: Lersivirine (if necessary) Drug: Lersivirine Drug: Placebo Drug: Moxifloxacin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A Lersivirine Tolerability	Drug: Lersivirine Lersivirine 2400 mg single dose Drug: Placebo Placebo single dose Drug: Lersivirine (if necessary) Lersivirine 2100 mg single dose (if necessary)
Experimental: Part B Thorough QTc	Drug: Lersivirine Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results) Drug: Placebo Placebo single dose Drug: Moxifloxacin Moxifloxacin 400 mg single dose

Arm

Intervention/Treatment

Experimental: Part A

Lersivirine Tolerability

Drug: Lersivirine

Lersivirine 2400 mg single dose

Drug: Placebo

Placebo single dose

Drug: Lersivirine (if necessary)

Lersivirine 2100 mg single dose (if necessary)

Experimental: Part B

Thorough QTc

Drug: Lersivirine

Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)

Drug: Placebo

Placebo single dose

Drug: Moxifloxacin

Moxifloxacin 400 mg single dose

Outcome Measures

Primary Outcome Measures

(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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bruxelles		Belgium	1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00936871

Other Study ID Numbers:

A5271032

First Posted:

Jul 10, 2009

Last Update Posted:

Sep 6, 2010

Last Verified:

Sep 1, 2010

Keywords provided by , ,

lersivirine QT QTc ECG HIV NNRTI

Additional relevant MeSH terms:

Moxifloxacin

Study Results

No Results Posted as of Sep 6, 2010