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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lexicon Pharmaceuticals

Criteria

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