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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01230385

Collaborator

ViiV Healthcare (Industry)

Enrollment

Locations

Arms

Duration (Months)

37.5

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Lersivirine Drug: Lersivirine Drug: Lersivirine Drug: Lersivirine Drug: Lersivirine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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
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

Outcome Measures

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. [21 days]

Secondary Outcome Measures

Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7 [21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).