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

NCT01230385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2011-05-17

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230385 on ClinicalTrials.gov