Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg Tablets

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01050751

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg tablet is similar to 3 x 250 mg tablets (750 mg total).

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

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-Label, Randomized, 2-Way Crossover Study To Estimate The Pharmacokinetics And Bioavailability Of Lersivirine (UK 453,061) Administered As A Single 750 Mg Tablet And 3 X 250 Mg Tablets In Healthy Subjects

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lersivirine (new formulation)	Drug: Lersivirine Oral Lersivirine 750 mg (1 x 750 mg) single dose
Active Comparator: Lersivirine (old formulation)	Drug: Lersivirine Oral Lersivirine 750 mg (3 x 250 mg) single dose

Arm

Intervention/Treatment

Experimental: Lersivirine (new formulation)

Drug: Lersivirine

Oral Lersivirine 750 mg (1 x 750 mg) single dose

Active Comparator: Lersivirine (old formulation)

Drug: Lersivirine

Oral Lersivirine 750 mg (3 x 250 mg) single dose

Outcome Measures

Primary Outcome Measures

To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets. [7 days]

Secondary Outcome Measures

To investigate the safety and tolerability of both single oral 750 mg (3 x 250 mg and 1 x 750 mg) dose of lersivirine. [7 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 between the ages of 18 and 55 years, inclusive.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
Total body weight >50 kg (110 lbs).

Exclusion Criteria:

Treatment with an investigational drug within 30 days or 5 half-lives or local regulation (whichever is longer) preceding the first dose of study medication.
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.
History of regular alcohol consumption exceeding 14 drinks/week for women and 21 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).