Healthy
Conditions
Keywords
Pharmacokinetics, Anemia, Chronic kidney disease, CKD, Renal impairment, Chronic renal insufficiency, Ferrous sulfate, Iron, End stage renal disease, Dialysis, Oral anemia treatment, Bioavailability, Erythropoietin, Hypoxia-inducible factor, Volunteers
Brief summary
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.
Interventions
DRUGAKB-6548 tablet, reference formulation given in the fasted state
DRUGAKB-6548 tablet, test formulation given in the fasted state.
DRUGAKB-6548 tablet, test formulation given in the fed state
Sponsors
Akebia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548 | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Bioavailability endpoints: Area under the concentration time curve from time 0 to infinity (AUC 0-inf) of AKB-6548 | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Bioavailability endpoints: Maximum observed plasma concentration (Cmax) of AKB-6548 | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Food Effect Endpoint: AKB-6548 AUC 0-t for the fed versus fasted administration of AKB-6548 tablets | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Food Effect Endpoint: AKB-6548 AUC 0-inf for the fed versus fasted administration of AKB-6548 tablets | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Food Effect Endpoint: AKB-6548 Cmax for the fed versus fasted administration of AKB-6548 tablets | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| AKB-6548: Apparent oral clearance (CL/F) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: Maximum observed plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| AKB-6548: Apparent volume of distribution during the terminal phase (Vz/F) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: Time to reach Cmax (Tmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: Terminal elimination rate constant (λz) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: Terminal elimination half-life (t1/2) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK Parameters of AKB-6548: AUC from time 0 to infinity (AUC 0-inf) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
Countries
United States
Outcome results
None listed