A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01334242

Enrollment

Registered

2011-04-13

Start date

2011-03-31

Completion date

Unknown

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacodynamics

Brief summary

The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.

Interventions

DRUGSchedule A

Dosing 1 hour before breakfast

DRUGSchedule B

Dosing 0.5 hour before breakfast

DRUGSchedule C

Dosing immediately before breakfast

DRUGSchedule D

Dosing immediately before lunch

DRUGSchedule E

Split dose, dosing 1 hour before breakfast and dinner

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Exclusion criteria

* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing * Use of any investigational agent or study treatment within 30 days of Day 1 * Use of any protein or antibody-based therapeutic agents within 3 months of Screening * Prior exposure to any SGLT inhibitor * Use of cigarettes or any tobacco products within 6 weeks prior to Screening and while participating in the study * History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption * History of any major surgery within 6 months of Screening * History of any hypersensitivity to the inactive components of LX4211 * History of renal disease or significantly abnormal kidney function tests * History of hepatic disease or significantly abnormal liver function tests * History of any active infection within 30 days of Day 1 * History of alcohol or substance abuse within 2 years prior to Day 1 * Positive urine glucose at Screening * Positive pregnancy test at Screening * Inability or difficulty swallowing whole tablets or capsules * Unable or unwilling to communicate or cooperate with the Investigator.

Design outcomes

Primary

Measure	Time frame
Peptide YY	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
Urinary glucose excretion	24 hours collection on Day -1 and Days 7-13
Fasting Plasma Glucose	Day -1 and Days 7-12

Secondary

Measure	Time frame	Description
Blood chemistry	Day -2, Day 7 and Day 13	Including albumin, ALP, ALT, AST, total bilirubin, glucose, BUN, calcium, carbon dioxide, chloride, cholesterol and triglycerides, creatinine, magnesium, phosphorus, potassium, sodium, protein, and uric acid.
Hematology	Day -2, Day 7 and Day 13	Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.
Number of Participants with Adverse Events	Day 1 to Day 14	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026