Expired Study
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San Antonio, Texas 78209


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.


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


Study is Available At:


Original ID:

LX4211.1-103-DDI


NCT ID:

NCT01292993


Secondary ID:

LX4211.103


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Lexicon Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ikenna Ogbaa, MD
Study Director
Lexicon Pharmaceuticals, Inc.

Study Dates

Start Date:February 2011
Primary Completion Date:March 2011
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 29, 2011
First Received Date:February 8, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Glucose-dependent insulinotropic peptide
Time Frame:Up to 43 days, including screening
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Glucagon-like peptide (GLP-1)
Time Frame:Up to 43 days, including screening
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Peptide YY
Time Frame:Up to 43 days, including screening
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Insulin
Time Frame:Up to 43 days, including screening
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Postprandial glucose
Time Frame:Up to 43 days, including screening
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Fasting plasma glucose
Time Frame:Up to 43 days, including screening
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Urinary glucose excretion
Time Frame:Up to 43 days, including screening
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Plasma concentration of LX4211 and metformin after concurrent single-dose administration
Time Frame:Up to 43 days, including screening
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:400 mg LX4211
Description:400 mg of LX4211 given as a solid oral dose form
Arm Name:Treatment A
Intervention Type:Drug
Name:1000 mg metformin
Description:1000 mg metformin given as a solid oral dose form
Arm Name:Treatment B

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment C
Description:400 mg LX4211 + 1000 mg metformin
Study Arm Type:Experimental
Arm Name:Treatment B
Description:1000 mg metformin
Study Arm Type:Experimental
Arm Name:Treatment A
Description:400 mg LX4211

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Lexicon Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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