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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936871
• Other study ID #: A5271032
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2009
• Last updated: September 1, 2010
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: September 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lersivirine
Lersivirine 2400 mg single dose
• Placebo
Placebo single dose
• Lersivirine (if necessary)
Lersivirine 2100 mg single dose (if necessary)
• Lersivirine
Lersivirine 2400 mg single dose (dose may be decreased pending Part A tolerability results)
• Placebo
Placebo single dose
• Moxifloxacin
Moxifloxacin 400 mg single dose

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.		1 day	Yes
Primary	(Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.		3 days	Yes
Secondary	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	Yes
Secondary	To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.		1 day	Yes
Secondary	To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.		1 day	No
Secondary	To assess the single dose pharmacokinetics of lersivirine.		1 - 2 days	No

External Links

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