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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230385
• Other study ID #: A5271049
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2010
• Last updated: May 16, 2011
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lersivirine
Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days
• Lersivirine
Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days
• Lersivirine
Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days
• Lersivirine
Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days
• Lersivirine
Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ViiV Healthcare

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7		21 days	No

External Links

•   To obtain contact information for a study center near you, click here.