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NCT Number: NCT01603485

Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lersivirine Immediate-Release (fasted)

Drug

Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)

Lersivirine Modified-Release #1 (fasted)

Drug

Single 500 mg dose of Lersivirine Modified-Release Tablet #1

Lersivirine Modified-Release #2 (fasted)

Drug

Single 500 mg dose of Lersivirine Modified-Release Tablet #2

Lersivirine Modified-Release #3 (fasted)

Drug

Single 500 mg dose of Lersivirine Modified-Release Tablet #3

Lersivirine Modified-Release (fed)

Drug

Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. Lersivirine Observed Plasma Concentration at time 24hr (C24)

    Time frame: T = 24 hours post dose

  4. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • ViiV Healthcare

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 22, 2012
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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