Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01220232

Collaborator

ViiV Healthcare (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Abacavir/Lamivudine Drug: Abacavir/Lamivudine Drug: Lersivirine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Abacavir/Lamivudine	Drug: Abacavir/Lamivudine Abacavir/Lamivudine 600/300 mg QD for 5 days
Experimental: Lersivirine + Abacavir/Lamivudine	Drug: Abacavir/Lamivudine Abacavir/Lamivudine 600/300 mg QD for 10 days Drug: Lersivirine Lersivirine 750 mg QD for 10 days

Arm

Intervention/Treatment

Active Comparator: Abacavir/Lamivudine

Drug: Abacavir/Lamivudine

Abacavir/Lamivudine 600/300 mg QD for 5 days

Experimental: Lersivirine + Abacavir/Lamivudine

Drug: Abacavir/Lamivudine

Abacavir/Lamivudine 600/300 mg QD for 10 days

Drug: Lersivirine

Lersivirine 750 mg QD for 10 days

Outcome Measures

Primary Outcome Measures

To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine. [17 days]

Secondary Outcome Measures

To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine. [17 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and/or female subjects.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
Total body weight >50 kg (110 lbs).

Exclusion Criteria:

History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
History of hypersensitivity to abacavir, lamivudine and/or lersivirine.