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The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKB-6548 | Experimental | AKB-6548 |
|
| AKB-6548 plus Ferrous Sulfate | Experimental | AKB-6548 plus ferrous sulfate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-6548 | Drug |
| ||
| Ferrous Sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of AKB-6548: Maximum plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| PK parameters of AKB-6548: Area under the curve from time 0 until the last quantifiable concentration (AUC [last]) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| PK parameters of AKB-6548: Area under the concentration-time curve from 0 to infinity (AUCinf) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of AKB-6548: Time to maximum plasma concentration (Tmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| PK parameters of AKB-6548: Terminal elimination rate constant (λz) | 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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| 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 |
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| ID | Term |
|---|---|
| C000624313 | vadadustat |
| C020748 | ferrous sulfate |
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| Drug |
|
| PK parameters of AKB-6548: Plasma half life (t1/2) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548: Apparent total systemic clearance (CL/F) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548: Apparent volume of distribution during the terminal elimination phase (VzF) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (λz) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Plasma half life (t1/2) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Area under the curve from time 0 until the last quantifiable concentration (AUC [last]) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Area under the concentration-time curve from 0 to infinity (AUCinf) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Ratio of metabolite to parent drug for maximum plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Ratio of metabolite to parent drug for are under the curve from time 0 until the last quantifiable concentration (AUC [last]) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Ratio of metabolite to parent drug for area under the concentration-time curve (AUC) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| 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 |