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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Randomized, Open-Label, Parallel Group Study To Investigate The Safety And Tolerability Of Multiple Dose Lersivirine (Proposed Phase 3 Formulation) For 21 Days In Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Lersivirine
* Drug: Lersivirine
* Drug: Lersivirine
* Drug: Lersivirine
* Drug: Lersivirine


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lersivirine 500 mg QD fasted (wet granulated tablet)<br> | Drug: Lersivirine<br>* Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days<br>|
| Experimental: Lersivirine 500 mg QD fed (wet granulated tablet)<br> | Drug: Lersivirine<br>* Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days<br>|
| Experimental: Lersivirine 750 mg QD fasted (wet granulated tablet)<br> | Drug: Lersivirine<br>* Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days<br>|
| Experimental: Lersivirine 750 mg QD fed (wet granulated tablet)<br> | Drug: Lersivirine<br>* Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days<br>|
| Active Comparator: Lersivirine 500 mg QD fasted (dry granulated tablet)<br> | Drug: Lersivirine<br>* Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7 |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lersivirine, UK-453, 061, safety, tolerability, pharmacokinetics, HIV, non-nucleoside reverse transcriptase inhibitor, NNRTI