Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/16/2018 |
| Start Date: | April 2015 |
| End Date: | April 2015 |
A Randomized, Open-Label, Single-Dose, Three-Period Crossover Study in Healthy Adults to Assess the Relative Bioavailability of Test and Reference Formulations of AKB-6548 Tablets and to Evaluate the Effect of Food on the Bioavailability of AKB-6548
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.
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.
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