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-LX1606

Phase 1

Carcinoid Syndrome | Small molecule | Other |Lexicon Pharmaceuticals, Inc.|Last Updated: Oct 23, 2013

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01932528An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in MalesPHASE1 COMPLETED 8Aug 1, 2013 -Oct 23, 20131 United Kingdom
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Study Endpoints
Primary Endpoints
Maximum plasma concentration of LX1606 and LX1033
7 days
Secondary Endpoints
Time to maximum plasma concentration of and LX1033
7 days
Determination of total radioactivity in blood and plasma
7 days
Mass balance recovery of total radioactivity in urine and feces
7 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
500 mg LX606EXPERIMENTALAll subjects will receive a single oral 500 mg dose of \[14C\]-LX1606.
Interventions
NameTypeDescription
500 mg [14C]-LX1606DRUG500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as \[14C\]-LX1606.
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects aged 30 to 65 years of age. * Male subjects and their partners must agree to use an adequate method of contraception * Historically able to produce a minimum of 1 bowel movement every day on most days Exclusion Criteria: * Female subjects * Use of any m...

Countries:United Kingdom
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