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Schedule A

Phase 1

Healthy | Small molecule | Other |Lexicon Pharmaceuticals, Inc.|Last Updated: May 19, 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

Clinical trial landscape

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. (LXRX). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other. It is not approved and remains in clinical testing.

What is Schedule A used for?

Schedule A is being studied for use in healthy subjects. The completed Phase 1 trial evaluated the pharmacodynamics of the drug relative to meals in healthy volunteers. No specific disease indication has been established for Schedule A at this time.

Who makes Schedule A?

Schedule A 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 small molecule drug.

What phase is Schedule A in?

Schedule A is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Schedule A in?

Schedule A has one completed clinical trial registered as NCT01334242, titled 'A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects.' This Phase 1 study enrolled 14 participants in the United States and was placebo-controlled, randomized, and double-blind.

Is Schedule A the same as LX4211?

Yes, Schedule A is also known as LX4211. The clinical trial NCT01334242 refers to the drug as LX4211, indicating that Schedule A and LX4211 are the same investigational compound being developed by Lexicon Pharmaceuticals.