Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02412449
- Run by
- Akebia Therapeutics
- People needed
- 18
- Starts
- 2015-04-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2018-11-14
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Kalamazoo, Michigan, United States
Full record on ClinicalTrials.gov
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