Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
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
1 other identifier
interventional
75
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Oct 2010
Typical duration for phase_1 healthy-volunteers
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 17, 2011
May 1, 2011
7 months
October 8, 2010
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7
21 days
Study Arms (5)
Lersivirine 500 mg QD fasted (wet granulated tablet)
EXPERIMENTALLersivirine 500 mg QD fed (wet granulated tablet)
EXPERIMENTALLersivirine 750 mg QD fasted (wet granulated tablet)
EXPERIMENTALLersivirine 750 mg QD fed (wet granulated tablet)
EXPERIMENTALLersivirine 500 mg QD fasted (dry granulated tablet)
ACTIVE COMPARATORInterventions
Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- ViiV Healthcarecollaborator
Study Sites (2)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 29, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 17, 2011
Record last verified: 2011-05