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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

Sponsor
Akebia Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03657290
Collaborator
(none)
54
Enrollment
1
Location
3
Arms
2.4
Actual Duration (Months)
22.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is a randomized, open-label, single-dose, three-period crossover study in healthy adults to assess the bioequivalence of 3 X 150 mg vadadustat tablets (Test) compared to a single 450 mg vadadustat tablet (reference). Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose. The study will also assess the effect of food on vadadustat bioavailability by evaluating the pharmacokinetics of the 450 mg tablet in fed and fasted subjects.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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 treatmentsThis 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Single-Dose, Three-Period Six-Sequence Crossover Study in Healthy Adults to Assess Bioequivalence Between Test and Reference Vadadustat 450 mg and 150 mg Tablets and to Determine Food Effect on the 450 mg Vadadustat Tablet.
Actual Study Start Date :
Aug 3, 2018
Actual Primary Completion Date :
Oct 16, 2018
Actual Study Completion Date :
Oct 16, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment A

vadadustat 3 X 150 mg Tablets in fasted subjects

Drug: vadadustat
Vadadustat Tablets
Other Names:
  • AKB-6548

    		•
    Active Comparator: Treatment B

    Vadadustat 1 X 450 mg Tablets in fasted subjects

    Drug: vadadustat
    Vadadustat Tablets
    Other Names:
  • AKB-6548

    		•
    Active Comparator: Treatment C

    vadadustat 1 X 450 mg Tablets in fed subjects

    Drug: vadadustat
    Vadadustat Tablets
    Other Names:
  • AKB-6548

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bioequivalence - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) [Baseline visit, 48 hours]

    2. Bioequivalence - Area under plasma concentration-time curve from 0 to infinity (AUCinf) [Baseline visit, 48 hours]

    3. Bioequivalence - Area under plasma concentration-time curve from 0 to last sampling point (AUCall) [Baseline visit, 48 hours]

    4. Bioequivalence - Observed Maximum concentration (Cmax) [Baseline visit, 48 hours]

    5. Measure Food Effect - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) [Baseline visit, 48 hours]

    6. Measure Food Effect - 2. Area under plasma concentration-time curve from 0 to infinity (AUCinf) [Baseline visit, 48 hours]

    7. Measure Food Effect - 2.3. Observed Maximum concentration (Cmax) [Baseline visit, 48 hours]

    Secondary Outcome Measures

    1. Time to reach Cmax [Baseline visit, 48 hours]

    2. Time to reach Tmax [Baseline visit, 48 hours]

    3. Mean residence time (MRT) [Baseline visit, 48 hours]

    4. Elimination rate constant (Kel) [Baseline visit, 48 hours]

    5. Apparent total body clearance (CL/F) [Baseline visit, 48 hours]

    6. Apparent volume of distribution (Vd/F) [Baseline visit, 48 hours]

    7. Terminal half-life (t1/2) [Baseline visit, 48 hours]

    8. Percentage of extrapolated area under the curve from time t to infinity (AUCextrap or Residual Area) [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:

    • 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.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Paraxel International Baltimore Maryland United States 21225

    Sponsors and Collaborators

    • Akebia Therapeutics

    Investigators

    • Study Director: Akebia Therapeutics, Sponsor GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Akebia Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03657290
    Other Study ID Numbers:
    • AKB-6548-CI-0028
    First Posted:
    Sep 5, 2018
    Last Update Posted:
    Mar 22, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Akebia Therapeutics
    Vadadustat
    healthy volunteers
    bioequivalence
    pharmacokinetics

    Study Results

    No Results Posted as of Mar 22, 2019