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Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat

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ClinicalTrials.gov Identifier: NCT03789032
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

Study Description
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Brief Summary:
This is a Phase 1, fixed sequence, open-label study to evaluate the effect of multiple oral doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat 300 mg in healthy male and female subjects.

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation Pharmacokinetics Drug: Vadadustat Drug: Rabeprazole Phase 1

Detailed Description:
This is a Phase 1, fixed sequence, open-label study in healthy adult subjects to evaluate the effect of multiple doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat in healthy male and female subjects. Approximately twenty (20) subjects, with at least 30% female subjects, will be enrolled to ensure 18 evaluable subjects. Subjects will be on study for up to 66 days, including a 28-day screening period, 9-day clinic period, and a 30-day follow- up period post last dose. Subjects who are confirmed eligible and receive at least one dose of study drug will be considered enrolled in the study. Blood samples for PK analysis will be collected at pre-defined time points throughout the study up to 48 hours post administration of vadadustat.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm fixed sequence study. Subjects will be administered vadadustat on day 1, rabeprazole on days 2 to 5, and vadadustat and rabeprazole on day 6.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Fixed Sequence, Open-label Study in Healthy Adult Subjects to Evaluate the Effect of Multiple Doses of Rabeprazole on the Pharmacokinetics of a Single Dose of Vadadustat
Actual Study Start Date : October 3, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 19, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rabeprazole and Vadadustat
Subjects will receive vadadustat 300 mg on day 1, rabeprazole 20 mg every 12 hours on days 2 through 5 and vadadustat 300 mg and rabeprazole on day 6
 Drug: Vadadustat
Vadadustat 300 mg

Drug: Rabeprazole
Oral Rabeprazole


Outcome Measures
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Primary Outcome Measures :
  1. Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for vadadustat [ Time Frame: Up to 10 weeks ]
  2. Area under plasma concentration-time curve from 0 to infinity (AUCinf) for vadadustat [ Time Frame: Up to 10 weeks ]
  3. Maximum observed plasma concentration (Cmax) for vadadustat [ Time Frame: Up to 10 weeks ]

Secondary Outcome Measures :
  1. Time to maximum observed plasma concentration (Tmax) of vadadustat [ Time Frame: Up to 10 weeks ]
  2. Elimination rate constant (Kel) of vadadustat [ Time Frame: Up to 10 weeks ]
  3. Terminal half-life (t½) of vadadustat [ Time Frame: Up to 10 weeks ]
  4. Apparent total body clearance (CL/F) of vadadustat [ Time Frame: Up to 10 weeks ]
  5. Percent of extrapolated area under the curve from time t to infinity (%AUCextrap) of vadadustat [ Time Frame: Baseline and end of study ]
  6. Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of vadadustat-O-glucuronide [ Time Frame: Up to 10 weeks ]
  7. Area under plasma concentration-time curve from 0 to infinity (AUCinf) of vadadustat-O-glucuronide [ Time Frame: Up to 10 weeks ]
  8. Maximum observed plasma concentration (Cmax) of vadadustat-O-glucuronide [ Time Frame: Up to 10 weeks ]
  9. Reporting of treatment emergent adverse event (TEAE) as reported by study subjects [ Time Frame: Up to 10 weeks ]

Eligibility Criteria
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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 or female between 18 and 55 years of age, inclusive, at time of informed consent
  • Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.

Exclusion Criteria:

  • Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
  • Positive test results for human immunodeficiency virus (HIV) antibody; Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening , or positive test results for human immunodeficiency virus antibody (HIVab) at Screening
  • Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.
Contacts and Locations
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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): NCT03789032


Locations
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Canada, Quebec
inVentiv Health Clinique Inc.
Québec City, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Akebia Therapeutics
Investigators
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Study Director: Akebia Therapeutics Sponsor GmbH
More Information
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Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT03789032     History of Changes
Other Study ID Numbers: AKB-6548-CI-0033
First Posted: December 28, 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
Rabeprazole
Pharmacokinetics
Additional relevant MeSH terms:
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Rabeprazole
Glycine
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycine Agents
Neurotransmitter Agents
Physiological Effects of Drugs