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

Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification Date
Completed	Healthy Volunteers	Pfizer Industry	July 7, 2009	September 1, 2010	September 2010

Study Type	Study Design	Phase	Enrollment	Start Date	End Date
Interventional	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment	Phase 1	66	January 2010	-

Locations

Facility	Address	Contact	Phone	Email	Status
Pfizer Investigational Site	Bruxelles 1070 Belgium	-	-	-	-

Intervention

Type	Intervention	Description
Drug	Lersivirine	Lersivirine 2400 mg single dose
Drug	Placebo	Placebo single dose
Drug	Lersivirine (if necessary)	Lersivirine 2100 mg single dose (if necessary)
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

Type	Measure	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

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

Eligibility

Gender	Minimum Age	Maximum Age	Healthy Volunteers
Both	-	55 Years	Accepts Healthy Volunteers

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.

References

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