Text Size

Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01230385
First received: October 8, 2010
Last updated: May 16, 2011
Last verified: May 2011
History of Changes

October 8, 2010
May 16, 2011
October 2010
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01230385 on ClinicalTrials.gov Archive Site
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2011
May 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; 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).
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium
 
NCT01230385
A5271049
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

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