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Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02412449
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

Brief Summary:
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: AKB-6548 tablet, reference formulation given in the fasted state Drug: AKB-6548 tablet, test formulation given in the fasted state. Drug: AKB-6548 tablet, test formulation given in the fed state Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-Label, Single-Dose, Three-Period Crossover Study in Healthy Adults to Assess the Relative Bioavailability of Test and Reference Formulations of AKB-6548 Tablets and to Evaluate the Effect of Food on the Bioavailability of AKB-6548
Study Start Date : April 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Treatment A
AKB-6548
Drug: AKB-6548 tablet, reference formulation given in the fasted state
Experimental: Treatment B
AKB-6548
Drug: AKB-6548 tablet, test formulation given in the fasted state.
Experimental: Treatment C
AKB-6548
Drug: AKB-6548 tablet, test formulation given in the fed state



Primary Outcome Measures :
  1. Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548 [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  2. Bioavailability endpoints: Area under the concentration time curve from time 0 to infinity (AUC 0-inf) of AKB-6548 [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  3. Bioavailability endpoints: Maximum observed plasma concentration (Cmax) of AKB-6548 [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  4. Food Effect Endpoint: AKB-6548 AUC 0-t for the fed versus fasted administration of AKB-6548 tablets [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  5. Food Effect Endpoint: AKB-6548 AUC 0-inf for the fed versus fasted administration of AKB-6548 tablets [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  6. Food Effect Endpoint: AKB-6548 Cmax for the fed versus fasted administration of AKB-6548 tablets [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]

Secondary Outcome Measures :
  1. PK Parameters of AKB-6548: Maximum observed plasma concentration (Cmax) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  2. PK Parameters of AKB-6548: Time to reach Cmax (Tmax) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  3. PK Parameters of AKB-6548: Terminal elimination rate constant (λz) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  4. PK Parameters of AKB-6548: Terminal elimination half-life (t1/2) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  5. PK Parameters of AKB-6548: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  6. PK Parameters of AKB-6548: AUC from time 0 to infinity (AUC 0-inf) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  7. AKB-6548: Apparent oral clearance (CL/F) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]
  8. AKB-6548: Apparent volume of distribution during the terminal phase (Vz/F) [ Time Frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose ]


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:

  • Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive.

Exclusion Criteria:

  • Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
  • Positive serology results for HBsAg, HCV, and HIV at Screening.
  • Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/min
  • Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months.
  • Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
  • Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.

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): NCT02412449


Locations
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United States, Michigan
Kalamazoo, Michigan, United States, 49007
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: NCT02412449    
Other Study ID Numbers: AKB-6548-CI-0013
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Akebia Therapeutics:
Pharmacokinetics
Anemia
Chronic kidney disease
CKD
Renal impairment
Chronic renal insufficiency
Ferrous sulfate
Iron
End stage renal disease
Dialysis
Oral anemia treatment
Bioavailability
Erythropoietin
Hypoxia-inducible factor
Volunteers
Additional relevant MeSH terms:
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Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs