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

NCT ID: NCT01292993

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

400 mg LX4211

Group Type EXPERIMENTAL

400 mg LX4211

Intervention Type DRUG

400 mg of LX4211 given as a solid oral dose form

Treatment B

1000 mg metformin

Group Type EXPERIMENTAL

1000 mg metformin

Intervention Type DRUG

1000 mg metformin given as a solid oral dose form

Treatment C

400 mg LX4211 + 1000 mg metformin

Group Type EXPERIMENTAL

400 mg LX4211

Intervention Type DRUG

400 mg of LX4211 given as a solid oral dose form

1000 mg metformin

Intervention Type DRUG

1000 mg metformin given as a solid oral dose form

Interventions

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400 mg LX4211

400 mg of LX4211 given as a solid oral dose form

Intervention Type DRUG

1000 mg metformin

1000 mg metformin given as a solid oral dose form

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Lexicon Pharmaceuticals, Inc.

Principal Investigators

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Ikenna Ogbaa, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

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Lexicon Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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LX4211.103

Identifier Type: OTHER

Identifier Source: secondary_id

LX4211.1-103-DDI

Identifier Type: -

Identifier Source: org_study_id