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

Lexicon Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Irritable Bowel Syndrome

Treatments

Drug: 250 mg capsule

Drug: 250 mg tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT01411800

LX1033.1-103-NRM

LX1033.103 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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