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.

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