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

NCT00936871 | Completed Phase 1

• 1 other identifier: A5271032
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

lersivirine QT QTc ECG HIV NNRTI

Outcome Measures

Primary Outcomes (2)

• (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 Outcomes (4)

• 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

Study Arms (2)

Part A

EXPERIMENTAL

Lersivirine Tolerability

Drug: Lersivirine; Drug: Placebo; Drug: Lersivirine (if necessary)

Part B

EXPERIMENTAL

Thorough QTc

Drug: Lersivirine; Drug: Placebo; Drug: Moxifloxacin

Interventions

Lersivirine DRUG

Lersivirine 2400 mg single dose

Part A

Placebo DRUG

Placebo single dose

Part A

Lersivirine (if necessary) DRUG

Lersivirine 2100 mg single dose (if necessary)

Part A

Moxifloxacin DRUG

Moxifloxacin 400 mg single dose

Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

UK 453,061; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 10, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 6, 2010

Record last verified: 2010-09

Locations

BE (1)