Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.103 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 400 mg LX4211 |
|
| Treatment B | Experimental | 1000 mg metformin |
|
| Treatment C | Experimental | 400 mg LX4211 + 1000 mg metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 mg LX4211 | Drug | 400 mg of LX4211 given as a solid oral dose form |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of LX4211 and metformin after concurrent single-dose administration | Up to 43 days, including screening |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary glucose excretion | Up to 43 days, including screening | |
| Fasting plasma glucose | Up to 43 days, including screening | |
| Postprandial glucose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ikenna Ogbaa, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | San Antonio | Texas | 78209 | United States |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1000 mg metformin | Drug | 1000 mg metformin given as a solid oral dose form |
|
| Up to 43 days, including screening |
| Insulin | Up to 43 days, including screening |
| Peptide YY | Up to 43 days, including screening |
| Glucagon-like peptide (GLP-1) | Up to 43 days, including screening |
| Glucose-dependent insulinotropic peptide | Up to 43 days, including screening |
| D004700 | Endocrine System Diseases |