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The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | AKB-6548 |
|
| Treatment B | Experimental | AKB-6548 |
|
| Treatment C | Experimental | AKB-6548 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-6548 tablet, reference formulation given in the fasted state | Drug |
| ||
| AKB-6548 tablet, test formulation given in the fasted state. |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548 | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| Bioavailability endpoints: Area under the concentration time curve from time 0 to infinity (AUC 0-inf) of AKB-6548 | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| Bioavailability endpoints: Maximum observed plasma concentration (Cmax) of AKB-6548 | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| Food Effect Endpoint: AKB-6548 AUC 0-t for the fed versus fasted administration of AKB-6548 tablets | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| Food Effect Endpoint: AKB-6548 AUC 0-inf for the fed versus fasted administration of AKB-6548 tablets | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| Food Effect Endpoint: AKB-6548 Cmax for the fed versus fasted administration of AKB-6548 tablets | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters of AKB-6548: Maximum observed plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| PK Parameters of AKB-6548: Time to reach Cmax (Tmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akebia Therapeutics | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kalamazoo | Michigan | 49007 | United States |
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| Drug |
|
| AKB-6548 tablet, test formulation given in the fed state | Drug |
|
| PK Parameters of AKB-6548: Terminal elimination rate constant (λz) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: Terminal elimination half-life (t1/2) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: AUC from time 0 to infinity (AUC 0-inf) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| AKB-6548: Apparent oral clearance (CL/F) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| AKB-6548: Apparent volume of distribution during the terminal phase (Vz/F) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000624313 | vadadustat |
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