Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects

NCT01916863 | Completed Phase 1

• 2 other identifiers: LX4211.1-111-NRMLX4211.111
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Change from baseline in rate of glucose appearance after meal (RaO)

  Days 1, 8, 15

Secondary Outcomes (4)

• Rate of total glucose appearance (RaT)

  Days 1, 8, 15

• Change from baseline in fasting plasma glucose

  Days 1, 8, 15

• Change from baseline in postprandial glucose

  Days 1, 8, 15

• Change from baseline in insulin

  Days 1, 8, 15

Study Arms (3)

LX4211

EXPERIMENTAL

400 mg of LX4211

Drug: LX4211 400 mg; Drug: canagliflozin 300 mg; Drug: LX4211 Placebo

Canagliflozin

ACTIVE COMPARATOR

300 mg canagliflozin

Drug: LX4211 400 mg; Drug: canagliflozin 300 mg; Drug: LX4211 Placebo

Placebo

PLACEBO COMPARATOR

LX4211 placebo

Drug: LX4211 400 mg; Drug: canagliflozin 300 mg; Drug: LX4211 Placebo

Interventions

LX4211 400 mg DRUG

Canagliflozin; LX4211; Placebo

canagliflozin 300 mg DRUG

Canagliflozin; LX4211; Placebo

LX4211 Placebo DRUG

Canagliflozin; LX4211; Placebo

Eligibility Criteria

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

You may qualify if:

• Adult subjects ≥18 to ≤55 years of age
• Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
• Body mass index (BMI) ≥18 and ≤35 kg/sq m
• Willing and able to provide written informed consent

You may not qualify if:

• Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 7 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 LX4211 or canagliflozin
• Daily use of \>5 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 bowel resection, any malabsorptive disorder, severe gastroparesis, any GI procedure for the purpose of weight loss which would slow gastric emptying
• History of any major surgery within 6 months prior to Screening
• History of any hypersensitivity to the inactive components of LX4211, inactive components of canagliflozin, acetaminophen oral solution or any inactive component of acetaminophen liquid preparation
• 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 prior to Day -1
• History of alcohol or substance abuse within 2 years prior to Day 1
• History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
• Donation or loss of \>500 mL of blood or blood product within 56 days of Day -1

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

Chula Vista, California, 91911, United States

Location

Related Publications (1)

• Powell DR, Zambrowicz B, Morrow L, Beysen C, Hompesch M, Turner S, Hellerstein M, Banks P, Strumph P, Lapuerta P. Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1235-49. doi: 10.1210/clinem/dgz258.

  PMID: 31837264 DERIVED

MeSH Terms

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Canagliflozin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Paul Strumph, M.D.

  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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 6, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

US (1)