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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001851-21 | EudraCT Number |
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This single-center, non-randomized, open-label, two treatment, two period, fixed sequence crossover study will investigate the effect of RG1662 treatment on the activity of key renal transporters in healthy male and female participants using metformin. The effect of RG1662 on other renal function parameters will also be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RG1662 plus metformin | Experimental |
| |
| metformin alone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipaque 300 | Other | 647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of metformin derived from plasma and urine concentrations of metformin: area under the concentration-time curve (AUC), maximum concentration (Cmax), renal clearance (CLr) [composite outcome measure] | Up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters derived from plasma concentrations of RG1662: AUC, Cmax, time to maximum concentration (Tmax), and minimum concentration (Ctrough)[composite outcome measure] | Up to 9 weeks | |
| Pharmacodynamics: renal function measured by derivation of glomerular filtration rate (GFR) from plasma concentrations of iohexol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| D007472 | Iohexol |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| RG1662 | Drug | Oral administration twice daily |
|
| metformin | Drug | Single 850 mg dose of metformin |
|
| Up to 9 weeks |
| Incidence of adverse events (AEs) | Up to 9 weeks |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |