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Completed

NCT Number: NCT01292993

A Study to Evaluate the 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

400 mg LX4211

Drug

400 mg of LX4211 given as a solid oral dose form

1000 mg metformin

Drug

1000 mg metformin given as a solid oral dose form

Primary outcomes

  1. Plasma concentration of LX4211 and metformin after concurrent single-dose administration

    Time frame: Up to 43 days, including screening

Secondary outcomes

  1. Urinary glucose excretion

    Time frame: Up to 43 days, including screening

  2. Fasting plasma glucose

    Time frame: Up to 43 days, including screening

  3. Postprandial glucose

    Time frame: Up to 43 days, including screening

  4. Insulin

    Time frame: Up to 43 days, including screening

  5. Peptide YY

    Time frame: Up to 43 days, including screening

  6. Glucagon-like peptide (GLP-1)

    Time frame: Up to 43 days, including screening

  7. Glucose-dependent insulinotropic peptide

    Time frame: Up to 43 days, including screening

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 10, 2011
Registry last updated
Mar 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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