Clinical trial NCT03639155: A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: vadadustat
AKB-6548
hypoxia-inducible factor
HIF
hypoxia-inducible factor prolyl-hydroxylase inhibitor
HIF-PHI
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
timeFrame: Baseline visit, 48 hours
measure: Area under plasma concentration-time curve from 0 to infinity (AUCinf)
timeFrame: Baseline visit, 48 hours
measure: Area under plasma concentration-time curve from 0 to last sampling point (AUCall)
timeFrame: Baseline visit, 48 hours
measure: Observed maximum concentration (Cmax)
timeFrame: Baseline visit, 48 hours
Secondary outcomes:
measure: Time to reach Cmax
timeFrame: Baseline visit, 48 hours
measure: Time to reach Tmax
timeFrame: Baseline visit, 48 hours
measure: Mean residence time (MRT)
timeFrame: Baseline visit, 48 hours
measure: Elimination rate constant (Kel)
timeFrame: Baseline visit, 48 hours
measure: Apparent total body clearance (CL/F)
timeFrame: Baseline visit, 48 hours
measure: Apparent volume of distribution (Vd/F)
timeFrame: Baseline visit, 48 hours
measure: Terminal half-life (t1/2)
timeFrame: Baseline visit, 48 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: Sponsor GmbH
name: Akebia
role: STUDY_DIRECTOR
References: