Healthy
Conditions
Keywords
vadadustat, AKB-6548, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI
Brief summary
This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared to a reference formulation of vadadustat (B)
Detailed description
This is a randomized, open-label, single-dose, two-period crossover study in healthy adults to assess the bioequivalence of a test formulation of vadadustat compared to the reference formulation of vadadustat. Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose.
Interventions
DRUGvadadustat test tablets
oral tablet
DRUGvadadustat reference tablets
oral tablet
Sponsors
Akebia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 55 years of age, inclusive, at time of informed consent. * Healthy subjects per Investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations. * Minimum weight of 45 kg with Body mass index (BMI) between 18 and 29.5 kg/m2, inclusive. * Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure * Willing and able to comply with the requirements of the study protocol.
Exclusion criteria
* Current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, history of cancer (except non-melanoma skin cancer) or history of chemotherapy use. * Any surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or gastric or duodenal ulcers. * History of severe allergic or anaphylactic reactions. * Chronic daily medication use. * History of drug abuse * Excessive alcohol consumption * Smoking and the use of nicotine-containing products * Consumption of grapefruit or grapefruit juice, pomelo, star fruit, Seville or Moro (blood) orange, or their associated products * Participation in another clinical trial or exposure to any investigational agent. * Donation of blood or significant blood loss or plasma donation. * Any condition that would interfere with the ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) | Baseline visit, 48 hours |
| Area under plasma concentration-time curve from 0 to infinity (AUCinf) | Baseline visit, 48 hours |
| Area under plasma concentration-time curve from 0 to last sampling point (AUCall) | Baseline visit, 48 hours |
| Observed maximum concentration (Cmax) | Baseline visit, 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Apparent total body clearance (CL/F) | Baseline visit, 48 hours |
| Time to reach Cmax | Baseline visit, 48 hours |
| Terminal half-life (t1/2) | Baseline visit, 48 hours |
| Apparent volume of distribution (Vd/F) | Baseline visit, 48 hours |
| Time to reach Tmax | Baseline visit, 48 hours |
| Mean residence time (MRT) | Baseline visit, 48 hours |
| Elimination rate constant (Kel) | Baseline visit, 48 hours |
Countries
United States
Outcome results
None listed