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Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01603485
First received: May 10, 2012
Last updated: September 18, 2012
Last verified: September 2012

May 10, 2012
September 18, 2012
June 2012
August 2012   (final data collection date for primary outcome measure)
  • Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
  • Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
  • Lersivirine Maximum Observed Plasma Concentration (Cmax) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01603485 on ClinicalTrials.gov Archive Site
  • Lersivirine Plasma Decay Half-Life (t1/2) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
  • Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
  • Lersivirine Observed Plasma Concentration at time 24hr (C24) [ Time Frame: T = 24 hours post dose ] [ Designated as safety issue: No ]
  • Lersivirine Last Observed Plasma Concentration (Clast) [ Time Frame: T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects
Open-Label, Randomized, Crossover Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-Release Lersivirine (UK-453,061) 500 mg in Healthy Subjects

The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different modified-release formulations of lersivirine and compare it to the PK of the immediate-release tablet. The effect of food on the PK of one of the modified-release tablets will also be assess along with the safety and tolerability of each treatment.

Not Provided
Interventional
Phase 1
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteer
  • Drug: Lersivirine Immediate-Release (fasted)
    Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)
  • Drug: Lersivirine Modified-Release #1 (fasted)
    Single 500 mg dose of Lersivirine Modified-Release Tablet #1
  • Drug: Lersivirine Modified-Release #2 (fasted)
    Single 500 mg dose of Lersivirine Modified-Release Tablet #2
  • Drug: Lersivirine Modified-Release #3 (fasted)
    Single 500 mg dose of Lersivirine Modified-Release Tablet #3
  • Drug: Lersivirine Modified-Release (fed)
    Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.
Experimental: Lersivirine
Interventions:
  • Drug: Lersivirine Immediate-Release (fasted)
  • Drug: Lersivirine Modified-Release #1 (fasted)
  • Drug: Lersivirine Modified-Release #2 (fasted)
  • Drug: Lersivirine Modified-Release #3 (fasted)
  • Drug: Lersivirine Modified-Release (fed)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 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;
  • Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication;
  • 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01603485
A5271050
No
Pfizer
Pfizer
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

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