Back to resultsA Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
400 mg LX4211
1000 mg metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Lexicon Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
400 mg LX4211
1000 mg metformin
400 mg LX4211 + 1000 mg metformin
Outcomes
Primary Outcome Measures
Plasma concentration of LX4211 and metformin after concurrent single-dose administration
Secondary Outcome Measures
Urinary glucose excretion
Fasting plasma glucose
Postprandial glucose
Insulin
Peptide YY
Glucagon-like peptide (GLP-1)
Glucose-dependent insulinotropic peptide
Full Information
NCT ID
NCT01292993
First Posted
February 8, 2011
Last Updated
March 29, 2011
Sponsor
Lexicon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01292993
Brief Title
A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Lexicon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
400 mg LX4211
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
1000 mg metformin
Arm Title
Treatment C
Arm Type
Experimental
Arm Description
400 mg LX4211 + 1000 mg metformin
Intervention Type
Drug
Intervention Name(s)
400 mg LX4211
Intervention Description
400 mg of LX4211 given as a solid oral dose form
Intervention Type
Drug
Intervention Name(s)
1000 mg metformin
Intervention Description
1000 mg metformin given as a solid oral dose form
Primary Outcome Measure Information:
Title
Plasma concentration of LX4211 and metformin after concurrent single-dose administration
Time Frame
Up to 43 days, including screening
Secondary Outcome Measure Information:
Title
Urinary glucose excretion
Time Frame
Up to 43 days, including screening
Title
Fasting plasma glucose
Time Frame
Up to 43 days, including screening
Title
Postprandial glucose
Time Frame
Up to 43 days, including screening
Title
Insulin
Time Frame
Up to 43 days, including screening
Title
Peptide YY
Time Frame
Up to 43 days, including screening
Title
Glucagon-like peptide (GLP-1)
Time Frame
Up to 43 days, including screening
Title
Glucose-dependent insulinotropic peptide
Time Frame
Up to 43 days, including screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ikenna Ogbaa, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects
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