An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
NCT ID: NCT01411800
Last Updated: 2012-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2011-08-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment A
500 mg LX1033, capsules administered two times per day orally
250 mg capsule
Two 250 mg capsules will be administered for 500 mg dose
Treatment B
500 mg LX1033, tablets administered two times per day orally
250 mg tablets
Two 250 mg tablets will be administered for a 500 mg dose
Interventions
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250 mg capsule
Two 250 mg capsules will be administered for 500 mg dose
250 mg tablets
Two 250 mg tablets will be administered for a 500 mg dose
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
Yes
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Ikenna Ogbaa, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Overland Park, Kansas, United States
Countries
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Other Identifiers
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LX1033.103
Identifier Type: OTHER
Identifier Source: secondary_id
LX1033.1-103-NRM
Identifier Type: -
Identifier Source: org_study_id