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This single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening and a 2-week follow-up, is up to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aleglitazar | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | Single oral dose Day 1, repeated oral dose once daily Days 5-14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax) | Day 14 pre-dose and up to 24 hours post-dose | |
| Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24) | Day 14 pre-dose and up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum concentration (Cmax) | 18 days | |
| Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax) | up to 5 days | |
| Single-dose pharmacokinetics: Half-life (t1/2) |
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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 |
|---|---|---|---|---|---|---|
| Beijing | 100083 | China |
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| ID | Term |
|---|---|
| C542437 | aleglitazar |
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| up to 5 days |
| Single-dose pharmacokinetics: Area under the concentration-time curve (AUC) | up to 5 days |
| Pharmacokinetics: Apparent oral plasma clearance (CL/F) | 18 days |
| Pharmacokinetics: Apparent volume of distribution (VZ/F) | 18 days |
| Pharmacokinetics: Accumulation index (Rac) | 18 days |
| Safety: Incidence of adverse events | approximately 10 months |