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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Lersivirine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01050751

A5271039

Details and patient eligibility

About

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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Lersivirine (new formulation)

Experimental group

Treatment:

Drug: Lersivirine

Drug: Lersivirine

Lersivirine (old formulation)

Active Comparator group

Treatment:

Drug: Lersivirine

Drug: Lersivirine