Clinical trial NCT01334242: A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacodynamics
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Urinary glucose excretion
timeFrame: 24 hours collection on Day -1 and Days 7-13
measure: Fasting Plasma Glucose
timeFrame: Day -1 and Days 7-12
measure: Postprandial Glucose
timeFrame: Day -1 and Days 7-12
measure: Insulin
timeFrame: Day -1 and Days 7-12
measure: Glucagon-like peptide 1 (total and active)
timeFrame: Day -1 and Days 7-12
measure: Peptide YY
timeFrame: Day -1 and Days 7-12
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Day 1 to Day 14
measure: Blood chemistry
timeFrame: Day -2, Day 7 and Day 13
measure: Hematology
timeFrame: Day -2, Day 7 and Day 13
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Ikenna Ogbaa, MD
role: STUDY_DIRECTOR
References:
citation: Zambrowicz B, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Boehm KA, Ruff D, Powell D, Sands A. Effects of LX4211, a dual sodium-dependent glucose cotransporters 1 and 2 inhibitor, on postprandial glucose, insulin, glucagon-like peptide 1, and peptide tyrosine tyrosine in a dose-timing study in healthy subjects. Clin Ther. 2013 Aug;35(8):1162-1173.e8. doi: 10.1016/j.clinthera.2013.06.011. Epub 2013 Jul 31.