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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: 250 mg capsule
* Drug: 250 mg tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>500 mg LX1033, capsules administered two times per day orally | Drug: 250 mg capsule<br>* Two 250 mg capsules will be administered for 500 mg dose<br>|
| Experimental: Treatment B<br>500 mg LX1033, tablets administered two times per day orally | Drug: 250 mg tablets<br>* Two 250 mg tablets will be administered for a 500 mg dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary 5-HIAA levels |  | 34 days | 
| Plasma 5-HIAA levels |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |