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

Sponsor

Akebia Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03639155

Collaborator

(none)

Enrollment

Location

Arms

1.3

Actual Duration (Months)

37.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: vadadustat reference tablets Drug: vadadustat test tablets	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 12, 2018

Actual Primary Completion Date :

May 23, 2018

Actual Study Completion Date :

May 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen A vadadustat reference tablets	Drug: vadadustat reference tablets oral tablet Other Names: AKB-6548
Experimental: Regimen B vadadustat test tablets	Drug: vadadustat test tablets oral tablet Other Names: AKB-6548

Arm

Intervention/Treatment

Experimental: Regimen A

vadadustat reference tablets

Drug: vadadustat reference tablets

oral tablet

Other Names:

AKB-6548

Experimental: Regimen B

vadadustat test tablets

Drug: vadadustat test tablets

oral tablet

Other Names:

AKB-6548

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Apparent volume of distribution (Vd/F) [Baseline visit, 48 hours]
Terminal half-life (t1/2) [Baseline visit, 48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.