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

This study has been completed.
Sponsor:
Information provided by:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01292993
First received: February 8, 2011
Last updated: March 29, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: 400 mg LX4211
Drug: 1000 mg metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Plasma concentration of LX4211 and metformin after concurrent single-dose administration [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary glucose excretion [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]
  • Postprandial glucose [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]
  • Peptide YY [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]
  • Glucagon-like peptide (GLP-1) [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]
  • Glucose-dependent insulinotropic peptide [ Time Frame: Up to 43 days, including screening ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: February 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292993

Locations
United States, Texas
Lexicon Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Ikenna Ogbaa, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Ikenna Ogbaa, MD, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01292993     History of Changes
Other Study ID Numbers: LX4211.1-103-DDI, LX4211.103
Study First Received: February 8, 2011
Last Updated: March 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014