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250 mg capsule, 250 mg tablets

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

250 mg capsule, 250 mg tablets · 1 trial · 1 indication

Phase 1 1
NCT01411800An Open-Label Study of Two Formulations of LX1033 in Healthy Human SubjectsIrritable Bowel Syndrome
COMPLETED28 Analytics
PHASE1COMPLETED
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
Irritable Bowel SyndromeUnlock trial analytics

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 to 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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Frequently asked questions about 250 mg capsule, 250 mg tablets

What is LX1033 used for?

LX1033 is an investigational drug being studied for the treatment of Irritable Bowel Syndrome. It is currently in Phase 1 clinical development and has been evaluated in a completed clinical trial involving healthy volunteers.

Who is developing LX1033?

LX1033 is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LXRX. The company is conducting clinical research on this investigational drug for gastrointestinal conditions.

What phase is LX1033 in?

LX1033 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, and it remains an investigational agent that has not yet been approved by regulatory authorities.

What clinical trials is LX1033 in?

LX1033 has been studied in a completed Phase 1 clinical trial registered as NCT01411800. This open-label study evaluated two formulations of LX1033 in 28 healthy human subjects in the United States, with participants aged 18 years and older.

Is LX1033 the same as LX1033?

LX1033 is the drug name used in clinical research. The completed trial NCT01411800 evaluated two different formulations of LX1033, both administered as 250 mg capsules or tablets, to compare their properties in healthy subjects.