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CompletedNCT01050751Updated Mar 9, 2010

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

A Phase 1 interventional study of Lersivirine and Lersivirine in Healthy Volunteers, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-09.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Bioavailability
  • Bioequivalence
  • Lersivirine
  • UK-453
  • 061
  • Pharmacokinetics
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 581 completed or terminated interventional studies of FDA-regulated products, 380 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Lersivirine (new formulation)

    Drug: Lersivirine

  • Active comparator
    Lersivirine (old formulation)

    Drug: Lersivirine

Interventions

  • DrugLersivirine

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

  • DrugLersivirine

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

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Pfizer Investigational Site
    Bruxelles, 1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01050751
Lead sponsor
Pfizer
First posted
Jan 15, 2010
Start date
Feb 2010
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Mar 9, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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