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

NCT01292993 | Completed Phase 1

• 2 other identifiers: LX4211.1-103-DDILX4211.103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  Up to 43 days, including screening

Secondary Outcomes (7)

• Urinary glucose excretion

  Up to 43 days, including screening

• Fasting plasma glucose

  Up to 43 days, including screening

• Postprandial glucose

  Up to 43 days, including screening

• Insulin

  Up to 43 days, including screening

• Peptide YY

  Up to 43 days, including screening

Study Arms (3)

Treatment A

EXPERIMENTAL

400 mg LX4211

Drug: 400 mg LX4211

Treatment B

EXPERIMENTAL

1000 mg metformin

Drug: 1000 mg metformin

Treatment C

EXPERIMENTAL

400 mg LX4211 + 1000 mg metformin

Drug: 400 mg LX4211; Drug: 1000 mg metformin

Interventions

400 mg LX4211 DRUG

400 mg of LX4211 given as a solid oral dose form

Treatment A; Treatment C

1000 mg metformin DRUG

1000 mg metformin given as a solid oral dose form

Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ikenna Ogbaa, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 10, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Last Updated: March 30, 2011

Record last verified: 2011-03

Locations

US (1)