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To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.
To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone and following multiple daily doses of AKB-6548.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib | Active Comparator | Celecoxib |
|
| AKB-6548 and Celecoxib | Experimental | AKB-6548; celecoxib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug |
|
| |
| AKB-6548 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters (Cmax) | maximum observed plasma concentration (Cmax) for celecoxib | pre-dose to 48 hours post-dose |
| PK parameters (time to reach Cmax ) | time to reach Cmax for celecoxib | pre-dose to 48 hours post-dose |
| PK parameters (t½) | terminal elimination half-life (t½) for celecoxib | from pre-dose to 48 hours post-dose |
| PK parameters (AUC0-t) | concentration (AUC0-t) for celecoxib | pre-dose to 48 hours post-dose |
| PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable) | area under the plasma concentration-time curve from 0 to last quantifiable | pre-dose to 48 hours post-dose |
| PK parameters (AUC0-inf) | AUC from time 0 to infinity (AUC0-inf) for celecoxib | from pre-dose to 48 hours post-dose |
| PK parameters (CL/F) | apparent oral clearance (CL/F) for celecoxib | pre-dose to 48 hours post-dose |
| PK parameters (Vz/F) | apparent volume of distribution during the terminal phase (Vz/F) for celecoxib |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability will be measured by vital signs | The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for vital signs, clinical laboratory assays | up to ten days |
| Safety and Tolerability will be monitoring of adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akebia Therapeutics | Sponsor GmbH | Study Director |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| C000624313 | vadadustat |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
|
| pre-dose to 48 hours post-dose |
The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for adverse events (AEs) |
| up to ten days |
| Safety and Tolerability will be measured by clinical assays | The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for clinical laboratory assays | up to ten days |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |