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Completed

NCT Number: NCT01230385

Safety And Tolerability Of Multiple Dose Lersivirine 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Lersivirine

Drug

Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days

Primary outcomes

  1. 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

Secondary outcomes

  1. Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • ViiV Healthcare

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2010
Registry last updated
May 17, 2011

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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