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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Lersivirine; Drug: Lersivirine; Drug: Lersivirine; Drug: Lersivirine; Drug: Lersivirine

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1070
    • Pfizer Investigational Site
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lersivirine 500 mg QD fasted (wet granulated tablet)	Drug: Lersivirine; Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
Experimental: Lersivirine 500 mg QD fed (wet granulated tablet)	Drug: Lersivirine; Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
Experimental: Lersivirine 750 mg QD fasted (wet granulated tablet)	Drug: Lersivirine; Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
Experimental: Lersivirine 750 mg QD fed (wet granulated tablet)	Drug: Lersivirine; Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
Active Comparator: Lersivirine 500 mg QD fasted (dry granulated tablet)	Drug: Lersivirine; Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days; Drug: Lersivirine; Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7	21 days

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: ViiV Healthcare

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 27, 2010
• First Posted (Estimate): October 29, 2010

Study Record Updates

• Last Update Posted (Estimate): May 17, 2011
• Last Update Submitted That Met QC Criteria: May 16, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: tolerability; safety; HIV; pharmacokinetics; non-nucleoside reverse transcriptase inhibitor; NNRTI; lersivirine; UK-453; 061
• Other Study ID Numbers: A5271049