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

NCT01334242 | Completed Phase 1

• 2 other identifiers: LX4211.1-104-NRMLX4211.104
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Pharmacodynamics

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• 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

Study Arms (2)

LX4211

EXPERIMENTAL

400 mg of LX4211 administered orally

Drug: Schedule A; Drug: Schedule B; Drug: Schedule C; Drug: Schedule D; Drug: Schedule E

Placebo

PLACEBO COMPARATOR

Nonidentical placebo administered orally

Drug: Schedule A; Drug: Schedule B; Drug: Schedule C; Drug: Schedule D; Drug: Schedule E

Interventions

Schedule A DRUG

Dosing 1 hour before breakfast

LX4211; Placebo

Schedule B DRUG

Dosing 0.5 hour before breakfast

LX4211; Placebo

Schedule C DRUG

Dosing immediately before breakfast

LX4211; Placebo

Schedule D DRUG

Dosing immediately before lunch

LX4211; Placebo

Schedule E DRUG

Split dose, dosing 1 hour before breakfast and dinner

LX4211; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• 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.

  PMID: 23911260 DERIVED

Study Officials

• Ikenna Ogbaa, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 13, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Last Updated: May 19, 2011

Record last verified: 2011-05

Locations

US (1)