An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
Phase 1
Completed
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Drug: 250 mg capsuleDrug: 250 mg tablets
- Registration Number
- NCT01411800
- Lead Sponsor
- Lexicon Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A 250 mg capsule 500 mg LX1033, capsules administered two times per day orally Treatment B 250 mg tablets 500 mg LX1033, tablets administered two times per day orally
- Primary Outcome Measures
Name Time Method Urinary 5-HIAA levels 34 days Plasma 5-HIAA levels 30 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Lexicon Investigational Site
🇺🇸Overland Park, Kansas, United States