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| ID | Type | Description | Link |
|---|---|---|---|
| I9J-MC-DIPA | Other Identifier | Eli Lilly and Company |
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This study will evaluate three new formulations of LY900020; a fixed dose, combination drug developed for people with type 2 diabetes mellitus. The study will be conducted in healthy participants to investigate the effect of different tablet formulations on the amount of LY900020 in the bloodstream. Side effects and tolerability will be documented. The study will last about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900020 Formulation 1 | Experimental | LY900020 Formulation 1 administered orally |
|
| LY900020 Formulation 2 | Experimental | LY900020 Formulation 2 administered orally |
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| LY900020 Formulation 3 | Experimental | LY900020 Formulation 3 administered orally |
|
| Reference Drugs | Active Comparator | Metformin XR, atorvastatin, and valsartan administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900020 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020 | PK: AUC of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm |
| PK: Maximum Observed Drug Concentration (Cmax) of LY900020 | PK: Cmax of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020 | PK: Tmax of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Metformin XR | Drug | Administered orally |
|
| Atorvastatin | Drug | Administered orally |
|
| Valsartan | Drug | Administered orally |
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013777 | Tetrazoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |