NCT01050751

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

Enrollment Period

28 days

First QC Date

January 14, 2010

Last Update Submit

March 8, 2010

Conditions

Healthy Volunteers

Keywords

BioavailabilityBioequivalenceLersivirineUK-453061Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets.

    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.

    7 days

Study Arms (2)

Lersivirine (new formulation)

EXPERIMENTAL
Drug: Lersivirine

Lersivirine (old formulation)

ACTIVE COMPARATOR
Drug: Lersivirine

Interventions

LersivirineDRUG

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

Lersivirine (new formulation)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Interventions

UK 453,061

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 9, 2010

Record last verified: 2010-03

Locations

BE(1)