• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Lexicon successfully completes phase I LX1033 trial

Lexicon successfully completes phase I LX1033 trial

July 29, 2011
CenterWatch Staff

Lexicon Pharmaceuticals has successfully completed a phase I clinical trial of LX1033, an orally-delivered small-molecule drug candidate for diarrhea-predominant irritable bowel syndrome (IBS-d).  Lexicon plans to move LX1033 forward into a phase II study in patients with IBS-d.

Top-line results demonstrated that LX1033 was well tolerated at all doses and produced a statistically significant reduction in serotonin synthesis compared to placebo, as measured by both plasma (p<0.001) and urinary (p<0.01) 5-hydroxyindoleacetic acid (5-HIAA), a biomarker for serotonin synthesis. Importantly, a greater reduction in serotonin synthesis was achieved with lower and less frequent dosing and at lower drug exposure levels than was observed with Lexicon's first generation serotonin synthesis inhibitor, LX1031, which had previously demonstrated clinical benefit to IBS patients in a phase IIa clinical trial as measured by both global assessment of adequate relief and stool consistency.

The LX1033 phase I trial was conducted as a randomized, placebo-controlled trial in healthy volunteers.  In the multiple-ascending dose portion of the study, doses of 250mg, 500mg and 750mg given three times daily, as well as 1,000mg twice daily, were administered over the course of 14 days.  There were eight healthy volunteers (six receiving active compound, two receiving placebo) in each dose group.  Study endpoints included safety and tolerability together with pharmacokinetic and pharmacodynamic parameters consisting of measures of both plasma and urinary 5-HIAA.  Data from the study showed that LX1033 produced a statistically significant decrease in both plasma and urinary 5-HIAA as compared to placebo at all doses tested.  The plasma measures of 5-HIAA in the recent study were obtained from a simple morning blood draw and correlated with results obtained by the traditional 24-hour urine collection method.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing