NCT01411800
Completed
Phase 1
A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects
ConditionsIrritable Bowel Syndrome
Overview
- Phase
- Phase 1
- Intervention
- 250 mg capsule
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Urinary 5-HIAA levels
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Treatment A
500 mg LX1033, capsules administered two times per day orally
Intervention: 250 mg capsule
Treatment B
500 mg LX1033, tablets administered two times per day orally
Intervention: 250 mg tablets
Outcomes
Primary Outcomes
Urinary 5-HIAA levels
Time Frame: 34 days
Plasma 5-HIAA levels
Time Frame: 30 days
Secondary Outcomes
- 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)
Study Sites (1)
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