An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects

A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects

The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: 250 mg capsule; Drug: 250 mg tablets

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult subjects age 18 to 55 years
• Vital signs acceptable at Screening
• Body mass index (BMI) between 18 and 35 kg/m^2 at Screening
• Considered to be in good health, as determined by the Investigator
• Normal ECG findings
• Negative urine screen for drugs of abuse and negative breath test for alcohol
• Negative hepatitis B surface antigen, hepatitis C antibody, and HIV1 and HIV2 antibody tests within the last 28 days
• Ability to provide written informed consent

Exclusion Criteria:

• Use of any medication (including acetaminophen) within 5 days of dosing
• Use of any investigational agent or selective serotonin reuptake inhibitors (SSRIs) within 30 days of study start
• Administration of any protein or antibodies within 90 days of study start
• Donation or loss of greater than 450 mL of blood within 45 days of study start
• Known history of hepatic disease or significantly abnormal liver function tests
• History of alcoholism or substance abuse within 3 years prior to study start
• Participation in any other clinical study within 30 days preceding the first dose of study drug
• Positive serum pregnancy test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; 500 mg LX1033, capsules administered two times per day orally	Drug: 250 mg capsule; Two 250 mg capsules will be administered for 500 mg dose
Experimental: Treatment B; 500 mg LX1033, tablets administered two times per day orally	Drug: 250 mg tablets; Two 250 mg tablets will be administered for a 500 mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary 5-HIAA levels	34 days
Plasma 5-HIAA levels	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration	32 days
Time at which maximum observed plasma concentration occurs	32 days
Half-life of the drug in plasma	32 days

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): July 20, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: LX1033.1-103-NRM; LX1033.103 (Other Identifier: Lexicon Pharmaceuticals, Inc.)