A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects

A Phase 1, Randomized, Open-Label, 3-Period, 3-Treatment, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of LX4211 and Metformin in Healthy Subjects

The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: 400 mg LX4211; Drug: 1000 mg metformin

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.
• Body mass index (BMI)≥18 to ≤35 kg/sq m
• Able to provide written consent
• Vital signs within sponsor-defined ranges

Exclusion Criteria:

• Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing
• No investigational agent or study treatment within 30 days prior to Day 1.
• No protein or antibody-based therapeutic agents within 3 months prior to screening
• Use of any tobacco product
• History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption
• History of any major surgery within 6 months prior to screening
• History of any serious adverse reaction or hypersensitivity to metformin or LX4211.
• History of renal disease or significantly abnormal kidney function test
• History of hepatic disease or significantly abnormal liver function test
• History of any active infection within 30 days prior to Day 1
• History of any surgical or medical condition or clinically significant laboratory or physical finding
• Positive urine glucose at Screening
• Use of drugs or alcohol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; 400 mg LX4211	Drug: 400 mg LX4211; 400 mg of LX4211 given as a solid oral dose form
Experimental: Treatment B; 1000 mg metformin	Drug: 1000 mg metformin; 1000 mg metformin given as a solid oral dose form
Experimental: Treatment C; 400 mg LX4211 + 1000 mg metformin	Drug: 400 mg LX4211; 400 mg of LX4211 given as a solid oral dose form; Drug: 1000 mg metformin; 1000 mg metformin given as a solid oral dose form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of LX4211 and metformin after concurrent single-dose administration	Up to 43 days, including screening

Secondary Outcome Measures

Outcome Measure	Time Frame
Urinary glucose excretion	Up to 43 days, including screening
Fasting plasma glucose	Up to 43 days, including screening
Postprandial glucose	Up to 43 days, including screening
Insulin	Up to 43 days, including screening
Peptide YY	Up to 43 days, including screening
Glucagon-like peptide (GLP-1)	Up to 43 days, including screening
Glucose-dependent insulinotropic peptide	Up to 43 days, including screening

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 8, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): March 30, 2011
• Last Update Submitted That Met QC Criteria: March 29, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Metformin; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
• Other Study ID Numbers: LX4211.1-103-DDI; LX4211.103 (Other Identifier: Lexicon Pharmaceuticals, Inc.)