Status:
COMPLETED
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01411800
Start Date
August 1 2011
End Date
May 1 2012
Last Update
July 20 2012
Active Locations (1)
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1
Lexicon Investigational Site
Overland Park, Kansas, United States, 66211