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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292993
• Other study ID #: LX4211.1-103-DDI
• Secondary ID: LX4211.103
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2011
• Last updated: March 29, 2011
• Start date: February 2011

Study information

• Verified date: March 2011
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 400 mg LX4211
400 mg of LX4211 given as a solid oral dose form
• 1000 mg metformin
1000 mg metformin given as a solid oral dose form

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of LX4211 and metformin after concurrent single-dose administration		Up to 43 days, including screening	No
Secondary	Urinary glucose excretion		Up to 43 days, including screening	No
Secondary	Fasting plasma glucose		Up to 43 days, including screening	No
Secondary	Postprandial glucose		Up to 43 days, including screening	No
Secondary	Insulin		Up to 43 days, including screening	No
Secondary	Peptide YY		Up to 43 days, including screening	No
Secondary	Glucagon-like peptide (GLP-1)		Up to 43 days, including screening	No
Secondary	Glucose-dependent insulinotropic peptide		Up to 43 days, including screening	No