Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects

A Phase 1b, Single-center, Double-blind, Randomized, Placebo-controlled Study on the Safety, Tolerability, and Pharmacokinetic Effects of Multiple Doses of LX4211 400 mg qd and LX4211 800 mg qd in Healthy Subjects

The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LX4211 400 mg; Drug: LX4211 Placebo; Drug: LX4211 800 mg

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States
      • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult subjects ≥ 18 to ≤ 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
• Willing and 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 dosing
• Use of any protein or antibody-based therapeutic agents within 3 months of Screening
• Prior exposure to LX4211
• Use of cigarettes or any tobacco products within 2 months 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 14 days prior to Day 1
• History of alcohol or substance abuse within 2 years prior to Day 1
• Donation or loss of >400 mL of blood or blood product within 3 months of dosing
• Positive urine glucose at Screening
• Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
• Inability or difficulty swallowing pills
• Unable or unwilling to communicate or cooperate with the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LX4211 Low Dose; 400 mg of LX4211 administered once daily for 10 consecutive days	Drug: LX4211 400 mg
Experimental: LX4211 High Dose; 800 mg of LX4211 administered once daily for 10 consecutive days	Drug: LX4211 800 mg
Placebo Comparator: Placebo; Identical placebo administered once daily for 10 consecutive days	Drug: LX4211 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events	Up to Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the curve	Days 1 through 10

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals
• Investigators: Study Director: Ikenna (Ike) Ogbaa, M.D., Lexicon Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 29, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 28, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; (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: LX4211.1-110-NRM; LX4211.110 (Other Identifier: Lexicon Pharmaceuticals, Inc.)