A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet

NCT03657290 | Completed Phase 1 FDA Drug

• 1 other identifier: AKB-6548-CI-0028
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.

Conditions

Healthy

Keywords

Vadadustat; healthy volunteers; bioequivalence; pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Bioequivalence - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)

  Baseline visit, 48 hours

• Bioequivalence - Area under plasma concentration-time curve from 0 to infinity (AUCinf)

  Baseline visit, 48 hours

• Bioequivalence - Area under plasma concentration-time curve from 0 to last sampling point (AUCall)

  Baseline visit, 48 hours

• Bioequivalence - Observed Maximum concentration (Cmax)

  Baseline visit, 48 hours

• Measure Food Effect - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)

  Baseline visit, 48 hours

• Measure Food Effect - 2. Area under plasma concentration-time curve from 0 to infinity (AUCinf)

  Baseline visit, 48 hours

• Measure Food Effect - 2.3. Observed Maximum concentration (Cmax)

  Baseline visit, 48 hours

Secondary Outcomes (8)

• 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 (3)

Treatment A

ACTIVE COMPARATOR

vadadustat 3 X 150 mg Tablets in fasted subjects

Drug: vadadustat

Treatment B

ACTIVE COMPARATOR

Vadadustat 1 X 450 mg Tablets in fasted subjects

Drug: vadadustat

Treatment C

ACTIVE COMPARATOR

vadadustat 1 X 450 mg Tablets in fed subjects

Drug: vadadustat

Interventions

vadadustat DRUG

Vadadustat Tablets

Also known as: AKB-6548

Treatment A; Treatment B; Treatment C

Eligibility Criteria

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

You may qualify if:

• Male or female subjects between ≥18 years and ≤55 years of age
• 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.
• Have a body weight ≥50 kg and body mass index (BMI) ≥18.5 kg/m2 to 29.5 kg/m2 inclusive
• Understands the procedures, provides ICF and willing to comply with study requirements
• 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)

Paraxel International

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

vadadustat

Study Officials

• Akebia Therapeutics

  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

Model Details: This is a randomized, open-label, single-dose, three-period, six- sequence crossover study in healthy adults. A total of 54 eligible subjects will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA). Refer to Treatment Sequences below. Each sequence is comprised of 3 treatments

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: August 3, 2018
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (1)