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

NCT03639155 | Completed Phase 1 FDA Drug

• 1 other identifier: AKB-6548-CI-0027
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

vadadustat; AKB-6548; hypoxia-inducible factor; HIF; hypoxia-inducible factor prolyl-hydroxylase inhibitor; HIF-PHI

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Time to reach Cmax

  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

• Apparent total body clearance (CL/F)

  Baseline visit, 48 hours

Study Arms (2)

Regimen A

EXPERIMENTAL

vadadustat reference tablets

Drug: vadadustat reference tablets

Regimen B

EXPERIMENTAL

vadadustat test tablets

Drug: vadadustat test tablets

Interventions

vadadustat reference tablets DRUG

oral tablet

Also known as: AKB-6548

Regimen A

vadadustat test tablets DRUG

oral tablet

Also known as: AKB-6548

Regimen B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (1)

Research Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

vadadustat

Study Officials

• Akebia

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: August 21, 2018
• Study Start: April 12, 2018
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (1)