A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults

Akebia Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: vadadustat test tablets

Drug: vadadustat reference tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT03639155

AKB-6548-CI-0027

Details and patient eligibility

About

This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared to a reference formulation of vadadustat (B)

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.