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

Healthy Clinical Trial

Official title:

A Randomized, Open-Label, Single-Dose, Two-Period Crossover Study in Healthy Adults to Assess Bioequivalence Between Test and Reference Formulations of Vadadustat 150 mg Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639155
• Other study ID #: AKB-6548-CI-0027
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2018
• Est. completion date: May 23, 2018

Study information

• Verified date: March 2019
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 23, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• vadadustat reference tablets
oral tablet
• vadadustat test tablets
oral tablet

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)		Baseline visit, 48 hours
Primary	Area under plasma concentration-time curve from 0 to infinity (AUCinf)		Baseline visit, 48 hours
Primary	Area under plasma concentration-time curve from 0 to last sampling point (AUCall)		Baseline visit, 48 hours
Primary	Observed maximum concentration (Cmax)		Baseline visit, 48 hours
Secondary	Time to reach Cmax		Baseline visit, 48 hours
Secondary	Time to reach Tmax		Baseline visit, 48 hours
Secondary	Mean residence time (MRT)		Baseline visit, 48 hours
Secondary	Elimination rate constant (Kel)		Baseline visit, 48 hours
Secondary	Apparent total body clearance (CL/F)		Baseline visit, 48 hours
Secondary	Apparent volume of distribution (Vd/F)		Baseline visit, 48 hours
Secondary	Terminal half-life (t1/2)		Baseline visit, 48 hours