Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01220232

Run by

Pfizer

People needed

14

Starts

2010-11-01

Expected to finish

2011-01-01

Last updated by the study team

2011-02-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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