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
This randomized, double-blind, placebo-controlled, parallel group study will investigate the safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with aspirin. The anticipated time on study drug is 5 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | repeated daily doses |
| |
| aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of aleglitazar in combination with aspirin on measured glomerular filtration rate | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of aleglitazar in combination with aspirin on renal plasma flow, filtration fraction and estimated glomerular filtration rate | 13 weeks | |
| To investigate the effect of aleglitazar in combination with aspirin on renin-angiotensin system and on anti-diuretic hormone |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | 78209 | United States |
Not provided
| ID | Term |
|---|---|
| C542437 | aleglitazar |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
repeated daily doses |
|
| placebo | Drug | repeated daily doses |
|
| 13 weeks |
| To investigate the effect of aspirin in combination with aleglitazar on platelet function and serum thromboxane B2 | 13 weeks |
| To investigate the pharmacokinetics of aleglitazar when co-administered with aspirin | 13 weeks |
| To investigate safety and tolerability of aleglitazar | 13 weeks |
| To investigate the effect of aleglitazar in combination with aspirin on electrolytes and osmolality clearances | 13 weeks |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |