Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01230385
First received: October 8, 2010
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.


Condition Intervention Phase
Healthy Volunteers
Drug: Lersivirine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-Label, Parallel Group Study To Investigate The Safety And Tolerability Of Multiple Dose Lersivirine (Proposed Phase 3 Formulation) For 21 Days In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7 [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lersivirine 500 mg QD fasted (wet granulated tablet) Drug: Lersivirine
Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days
Experimental: Lersivirine 500 mg QD fed (wet granulated tablet) Drug: Lersivirine
Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days
Experimental: Lersivirine 750 mg QD fasted (wet granulated tablet) Drug: Lersivirine
Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days
Experimental: Lersivirine 750 mg QD fed (wet granulated tablet) Drug: Lersivirine
Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days
Active Comparator: Lersivirine 500 mg QD fasted (dry granulated tablet) Drug: Lersivirine
Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230385

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01230385     History of Changes
Other Study ID Numbers: A5271049
Study First Received: October 8, 2010
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
lersivirine
UK-453
061
safety
tolerability
pharmacokinetics
HIV
non-nucleoside reverse transcriptase inhibitor
NNRTI

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014