Back to resultsAn Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
250 mg capsule
250 mg tablets
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
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
Sites / Locations
- Lexicon Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Arm Description
500 mg LX1033, capsules administered two times per day orally
500 mg LX1033, tablets administered two times per day orally
Outcomes
Primary Outcome Measures
Urinary 5-HIAA levels
Plasma 5-HIAA levels
Secondary Outcome Measures
Maximum observed plasma concentration
Time at which maximum observed plasma concentration occurs
Half-life of the drug in plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01411800
Brief Title
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
Official Title
A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
500 mg LX1033, capsules administered two times per day orally
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
500 mg LX1033, tablets administered two times per day orally
Intervention Type
Drug
Intervention Name(s)
250 mg capsule
Intervention Description
Two 250 mg capsules will be administered for 500 mg dose
Intervention Type
Drug
Intervention Name(s)
250 mg tablets
Intervention Description
Two 250 mg tablets will be administered for a 500 mg dose
Primary Outcome Measure Information:
Title
Urinary 5-HIAA levels
Time Frame
34 days
Title
Plasma 5-HIAA levels
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration
Time Frame
32 days
Title
Time at which maximum observed plasma concentration occurs
Time Frame
32 days
Title
Half-life of the drug in plasma
Time Frame
32 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ikenna Ogbaa, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
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