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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050751
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : March 9, 2010
Information provided by:

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 Phase 1

Study Type : Interventional  (Clinical Trial)
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 : February 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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

Primary Outcome Measures :
  1. To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. To investigate the safety and tolerability of both single oral 750 mg (3 x 250 mg and 1 x 750 mg) dose of lersivirine. [ Time Frame: 7 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050751

Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01050751     History of Changes
Other Study ID Numbers: A5271039
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010

Keywords provided by Pfizer: