Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Nov 2010
Shorter than P25 for phase_1 healthy-volunteers
1 active site
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
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 4, 2011
February 1, 2011
2 months
October 12, 2010
February 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.
17 days
Secondary Outcomes (1)
To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.
17 days
Study Arms (2)
Abacavir/Lamivudine
ACTIVE COMPARATORLersivirine + Abacavir/Lamivudine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight \>50 kg (110 lbs).
You may not qualify if:
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- History of hypersensitivity to abacavir, lamivudine and/or lersivirine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- ViiV Healthcarecollaborator
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 13, 2010
Study Start
November 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 4, 2011
Record last verified: 2011-02