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The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKB-6548 (therapeutic dose) | Experimental |
| |
| AKB-6548 (supratherapeutic dose) | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Moxifloxacin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-6548 (therapeutic dose) | Drug | Single oral dose of AKB-6548 at a therapeutic dose level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration. | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval | multiple timepoint evaluations from pre-dose to 24 hours post-dose | |
| Categorical outliers defined as QTcF >450 msec, 480 msec and 500 msec at any timepoint and change-from-baseline QTcF (ΔQTcF) >30 msec (increased by 30 msec) and >60 msec |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akebia Therapeutics | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evansville | Indiana | United States |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C000624313 | vadadustat |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| AKB-6548 (supratherapeutic dose) | Drug | Single oral dose of AKB-6548 at a supratherapeutic dose level |
|
| Placebo | Drug | Single oral dose of placebo |
|
| Moxifloxacin | Drug | Single oral dose of 400 mg moxifloxacin |
|
| multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Categorical outliers for HR, PR interval, QRS interval | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Frequency of T wave morphology changes | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following moxifloxacin administration | multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Safety parameters to include adverse events; changes in routine clinical laboratory measures including chemistry, hematology, and urinalysis; and clinically significant changes noted during physical examinations or in vital signs | from first dose of study medication through the final protocol required visit |
| 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 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |