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

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01220232
Pfizer
Completed
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

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Descriptive Information
Brief Title  ICMJE Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Official Title  ICMJE Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Abacavir/Lamivudine
    Intervention: Drug: Abacavir/Lamivudine
  • Experimental: Lersivirine + Abacavir/Lamivudine
    Interventions:
    • Drug: Abacavir/Lamivudine
    • Drug: Lersivirine
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2010)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion DateJanuary 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01220232
Other Study ID Numbers  ICMJE A5271048
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE ViiV Healthcare
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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