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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Lersivirine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01230385

A5271049

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 5 patient groups

Lersivirine 500 mg QD fasted (wet granulated tablet)

Experimental group

Treatment:

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Lersivirine 500 mg QD fed (wet granulated tablet)

Experimental group

Treatment:

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Lersivirine 750 mg QD fasted (wet granulated tablet)

Experimental group

Treatment:

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Lersivirine 750 mg QD fed (wet granulated tablet)

Experimental group

Treatment:

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Lersivirine 500 mg QD fasted (dry granulated tablet)

Active Comparator group

Treatment:

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine

Drug: Lersivirine