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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

October 12, 2010
February 3, 2011
November 2010
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01220232 on ClinicalTrials.gov Archive Site
To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine. [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]
To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine. [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Abacavir/Lamivudine
    Abacavir/Lamivudine 600/300 mg QD for 5 days
  • Drug: Abacavir/Lamivudine
    Abacavir/Lamivudine 600/300 mg QD for 10 days
  • Drug: Lersivirine
    Lersivirine 750 mg QD for 10 days
  • Active Comparator: Abacavir/Lamivudine
    Intervention: Drug: Abacavir/Lamivudine
  • Experimental: Lersivirine + Abacavir/Lamivudine
    Interventions:
    • Drug: Abacavir/Lamivudine
    • Drug: Lersivirine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01220232
A5271048
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP