Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Anemia, Chronic kidney disease, CKD, Chronic renal insufficiency, Renal impairment, Ferrous sulfate, Iron, Drug-drug interaction, End stage renal disease, Dialysis, Erythropoietin, Oral anemia treatment, Hypoxia-induciable factor, HIF, Hypoxia-induciable factor prolyl-hydroxylase inhibitor, HIF-PHI
Brief summary
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.
Interventions
DRUGAKB-6548
DRUGFerrous Sulfate
Sponsors
Akebia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters of AKB-6548: Maximum plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548: Area under the curve from time 0 until the last quantifiable concentration (AUC [last]) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548: Area under the concentration-time curve from 0 to infinity (AUCinf) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of AKB-6548: Apparent total systemic clearance (CL/F) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548: Apparent volume of distribution during the terminal elimination phase (VzF) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (λz) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548: Time to maximum plasma concentration (Tmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Area under the curve from time 0 until the last quantifiable concentration (AUC [last]) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Area under the concentration-time curve from 0 to infinity (AUCinf) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Ratio of metabolite to parent drug for maximum plasma concentration (Cmax) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Ratio of metabolite to parent drug for are under the curve from time 0 until the last quantifiable concentration (AUC [last]) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| Ratio of metabolite to parent drug for area under the concentration-time curve (AUC) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
| PK parameters of AKB-6548 metabolites: Plasma half life (t1/2) | 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: Plasma half life (t1/2) | Multiple timepoint evaluations from pre-dose to 24 hours post-dose |
Countries
United States
Outcome results
None listed