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Schedule A

Phase 1

Undisclosed | Small molecule | Other |Lexicon Pharmaceuticals, Inc.|Trials Updated: May 19, 2011

Schedule A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Schedule A clinical trials

Schedule A · 1 trial · 1 indication

Phase 1 1
NCT01334242A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy SubjectsHealthy
COMPLETED14 Analytics
PHASE1COMPLETED
A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
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Study Endpoints

Primary Endpoints

Urinary glucose excretion
24 hours collection on Day -1 and Days 7-13
Fasting Plasma Glucose
Day -1 and Days 7-12
Postprandial Glucose
Day -1 and Days 7-12
Insulin
Day -1 and Days 7-12
Glucagon-like peptide 1 (total and active)
Day -1 and Days 7-12
Peptide YY
Day -1 and Days 7-12

Secondary Endpoints

Number of Participants with Adverse Events
Day 1 to Day 14
Blood chemistry
Day -2, Day 7 and Day 13
Hematology
Day -2, Day 7 and Day 13
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LX4211EXPERIMENTAL400 mg of LX4211 administered orally
PlaceboPLACEBO_COMPARATORNonidentical placebo administered orally

Interventions

NameTypeDescription
Schedule ADRUGDosing 1 hour before breakfast
Schedule BDRUGDosing 0.5 hour before breakfast
Schedule CDRUGDosing immediately before breakfast
Schedule DDRUGDosing immediately before lunch
Schedule EDRUGSplit dose, dosing 1 hour before breakfast and dinner
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adults ≥18 and ≤55 years of age * Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm * Body mass index (BMI) ≥18 and ≤35 kg/sq m * Able to provide written informed consent Excl...

Countries:United States
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Frequently asked questions about Schedule A

What is Schedule A?

Schedule A is an investigational small molecule being developed by Lexicon Pharmaceuticals, Inc. It has completed a Phase 1 clinical trial in healthy adult volunteers. The specific therapeutic indication for Schedule A has not been publicly disclosed, and the compound remains in early-stage clinical development.

Who makes Schedule A?

Schedule A is being developed by Lexicon Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol LXRX. Lexicon is the sponsor of the clinical program for this investigational small molecule.

What phase is Schedule A in?

Schedule A is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.

What clinical trials is Schedule A in?

Schedule A has been studied in one completed Phase 1 trial, NCT01334242, titled "A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects." The trial enrolled 14 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.

Is Schedule A the same as LX4211?

Yes, Schedule A is also known as LX4211. The completed Phase 1 trial NCT01334242 was conducted under the LX4211 designation, so references to LX4211 in the clinical literature refer to the same investigational compound being developed by Lexicon Pharmaceuticals.