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

NCT ID: NCT03639155

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2018-05-23

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen A

vadadustat reference tablets

Group Type: EXPERIMENTAL

vadadustat reference tablets

Intervention Type: DRUG

oral tablet

Regimen B

vadadustat test tablets

Group Type: EXPERIMENTAL

vadadustat test tablets

Intervention Type: DRUG

oral tablet

Interventions

vadadustat reference tablets

oral tablet

Intervention Type: DRUG

vadadustat test tablets

oral tablet

Intervention Type: DRUG

Other Intervention Names

AKB-6548; AKB-6548

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akebia Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akebia

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Research Site

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

AKB-6548-CI-0027

Identifier Type: -

Identifier Source: org_study_id