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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lersivirine

• Registration Number: NCT01050751
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Study Start: 2010-02
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-08
• Last Update Posted: 2010-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lersivirine (old formulation)	Lersivirine	-
Lersivirine (new formulation)	Lersivirine	-

Primary Outcome Measures

Name	Time	Method
To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets.	7 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium