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

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01220232
First received: October 12, 2010
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Abacavir/Lamivudine
Drug: Lersivirine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine. [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine. [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: November 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220232

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01220232     History of Changes
Other Study ID Numbers: A5271048
Study First Received: October 12, 2010
Last Updated: February 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lersivirine
UK-453
061
NNRTI
Abacavir
Lamivudine
Combivir
Pharmacokinetics
Drug Interaction
HIV
AIDS

Additional relevant MeSH terms:
Abacavir
Lamivudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014