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

NCT03789032 | Completed Phase 1 FDA Drug

• 1 other identifier: AKB-6548-CI-0033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Interaction Potentiation; Pharmacokinetics

Keywords

Vadadustat; Rabeprazole; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

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

  Up to 10 weeks

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

  Up to 10 weeks

• Maximum observed plasma concentration (Cmax) for vadadustat

  Up to 10 weeks

Secondary Outcomes (9)

• Time to maximum observed plasma concentration (Tmax) of vadadustat

  Up to 10 weeks

• Elimination rate constant (Kel) of vadadustat

  Up to 10 weeks

• Terminal half-life (t½) of vadadustat

  Up to 10 weeks

• Apparent total body clearance (CL/F) of vadadustat

  Up to 10 weeks

• Percent of extrapolated area under the curve from time t to infinity (%AUCextrap) of vadadustat

  Baseline and end of study

Study Arms (1)

Rabeprazole and Vadadustat

EXPERIMENTAL

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; Drug: Rabeprazole

Interventions

Vadadustat DRUG

Vadadustat 300 mg

Rabeprazole and Vadadustat

Rabeprazole DRUG

Oral Rabeprazole

Rabeprazole and Vadadustat

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (1)

inVentiv Health Clinique Inc.

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Interventions

vadadustat; Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Akebia Therapeutics

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: October 3, 2018
• Primary Completion: November 9, 2018
• Study Completion: November 19, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

CA (1)