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Phase 1

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Lexicon Pharmaceuticals, Inc.|Last Updated: Jul 20, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01411800An Open-Label Study of Two Formulations of LX1033 in Healthy Human SubjectsPHASE1 COMPLETED 28Aug 1, 2011May 1, 2012Jul 20, 20121 United States
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Study Endpoints
Primary Endpoints
Urinary 5-HIAA levels
34 days
Plasma 5-HIAA levels
30 days
Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTAL500 mg LX1033, capsules administered two times per day orally
Treatment BEXPERIMENTAL500 mg LX1033, tablets administered two times per day orally
Interventions
NameTypeDescription
250 mg capsuleDRUGTwo 250 mg capsules will be administered for 500 mg dose
250 mg tabletsDRUGTwo 250 mg tablets will be administered for a 500 mg dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 nega...

Countries:United States
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