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Trial record 1 of 1 for:    NCT01230385
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Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01230385
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : May 17, 2011
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 8, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE October 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days. [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01230385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7 [ Time Frame: 21 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7. [ Time Frame: 21 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
Official Title  ICMJE Randomized, Open-Label, Parallel Group Study To Investigate The Safety And Tolerability Of Multiple Dose Lersivirine (Proposed Phase 3 Formulation) For 21 Days In Healthy Subjects
Brief Summary Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Lersivirine
    Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days
  • Drug: Lersivirine
    Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days
  • Drug: Lersivirine
    Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days
  • Drug: Lersivirine
    Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days
  • Drug: Lersivirine
    Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
Study Arms  ICMJE
  • Experimental: Lersivirine 500 mg QD fasted (wet granulated tablet)
    Intervention: Drug: Lersivirine
  • Experimental: Lersivirine 500 mg QD fed (wet granulated tablet)
    Intervention: Drug: Lersivirine
  • Experimental: Lersivirine 750 mg QD fasted (wet granulated tablet)
    Intervention: Drug: Lersivirine
  • Experimental: Lersivirine 750 mg QD fed (wet granulated tablet)
    Intervention: Drug: Lersivirine
  • Active Comparator: Lersivirine 500 mg QD fasted (dry granulated tablet)
    Intervention: 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 27, 2010)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 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; and a total body weight >50 kg (110 lbs).
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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 Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230385
Other Study ID Numbers  ICMJE A5271049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE ViiV Healthcare
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

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