Expired Study
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Kalamazoo, Michigan 49007


Purpose:

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.


Criteria:

Inclusion Criteria: - Healthy male subjects 18 to 55 years of age with a body mass index between 18 and 30 kg/m2 - Participants and their partners must use a highly effective form of contraception during the study and for 1 month following discharge from the Clinical Research Unit (CRU) - Subjects must discontinue all iron preparations for 14 days prior to study drug administration Exclusion Criteria: - Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease - Positive serology results for HBsAg, HCV, and HIV at Screening - Renal impairment (estimated glomerular filtration rate (eGFR) of <65mL/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


NCT ID:

NCT02327546


Primary Contact:

Study Chair
Akshay Buch
Akebia Therapeutics, Inc.


Backup Contact:

N/A


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: November 23, 2017

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