Expired Study
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Kalamazoo, Michigan 49007


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.


Inclusion Criteria: - Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive. Exclusion Criteria: - Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease. - Positive serology results for HBsAg, HCV, and HIV at Screening. - Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/min - Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months. - Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug. - Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.



Primary Contact:

Study Chair
Akshay Buch
Akebia Therapeutics, Inc.

Backup Contact:


Location Contact:

Kalamazoo, Michigan 49007
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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