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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657290
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

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
Healthy Drug: vadadustat 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.

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Study Type : Interventional  (Clinical Trial)
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 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 : August 3, 2018
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : October 16, 2018

Arm Intervention/treatment
Active Comparator: Treatment A
vadadustat 3 X 150 mg Tablets in fasted subjects
Drug: vadadustat
Vadadustat Tablets
Other Name: AKB-6548

Active Comparator: Treatment B
Vadadustat 1 X 450 mg Tablets in fasted subjects
Drug: vadadustat
Vadadustat Tablets
Other Name: AKB-6548

Active Comparator: Treatment C
vadadustat 1 X 450 mg Tablets in fed subjects
Drug: vadadustat
Vadadustat Tablets
Other Name: AKB-6548




Primary Outcome Measures :
  1. Bioequivalence - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) [ Time Frame: Baseline visit, 48 hours ]
  2. Bioequivalence - Area under plasma concentration-time curve from 0 to infinity (AUCinf) [ Time Frame: Baseline visit, 48 hours ]
  3. Bioequivalence - Area under plasma concentration-time curve from 0 to last sampling point (AUCall) [ Time Frame: Baseline visit, 48 hours ]
  4. Bioequivalence - Observed Maximum concentration (Cmax) [ Time Frame: Baseline visit, 48 hours ]
  5. Measure Food Effect - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) [ Time Frame: Baseline visit, 48 hours ]
  6. Measure Food Effect - 2. Area under plasma concentration-time curve from 0 to infinity (AUCinf) [ Time Frame: Baseline visit, 48 hours ]
  7. Measure Food Effect - 2.3. Observed Maximum concentration (Cmax) [ Time Frame: Baseline visit, 48 hours ]

Secondary Outcome Measures :
  1. Time to reach Cmax [ Time Frame: Baseline visit, 48 hours ]
  2. Time to reach Tmax [ Time Frame: Baseline visit, 48 hours ]
  3. Mean residence time (MRT) [ Time Frame: Baseline visit, 48 hours ]
  4. Elimination rate constant (Kel) [ Time Frame: Baseline visit, 48 hours ]
  5. Apparent total body clearance (CL/F) [ Time Frame: Baseline visit, 48 hours ]
  6. Apparent volume of distribution (Vd/F) [ Time Frame: Baseline visit, 48 hours ]
  7. Terminal half-life (t1/2) [ Time Frame: Baseline visit, 48 hours ]
  8. Percentage of extrapolated area under the curve from time t to infinity (AUCextrap or Residual Area) [ Time Frame: Baseline visit, 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657290


Locations
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United States, Maryland
Paraxel International
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Akebia Therapeutics
Investigators
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Study Director: Akebia Therapeutics Sponsor GmbH
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Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT03657290    
Other Study ID Numbers: AKB-6548-CI-0028
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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