Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.

Key facts

Study ID

NCT01230385

Run by

Pfizer

People needed

75

Starts

2010-10-01

Expected to finish

2011-05-01

Last updated by the study team

2011-05-17

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; and a total body weight >50 kg (110 lbs).
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• 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.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Where it is running

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

Full record on ClinicalTrials.gov

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