Status:
COMPLETED
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Lead Sponsor:
Pfizer
Collaborating Sponsors:
ViiV Healthcare
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 pharmacokine...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01220232
Start Date
November 1 2010
End Date
January 1 2011
Last Update
February 4 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511