DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Abacavir/Lamivudine (Drug); Abacavir/Lamivudine (Drug); Lersivirine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.

Secondary outcome: To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information

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

Starting date: November 2010
Last updated: February 3, 2011

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017