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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789032
• Other study ID #: AKB-6548-CI-0033
• Status: Completed
• Phase: Phase 1
• Start date: October 3, 2018
• Est. completion date: November 19, 2018

Study information

• Verified date: March 2019
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 19, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Interaction Potentiation
• Pharmacokinetics

Intervention

Drug:
• Vadadustat
Vadadustat 300 mg
• Rabeprazole
Oral Rabeprazole

Locations

Country	Name	City	State
Canada	inVentiv Health Clinique Inc.	Québec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for vadadustat		Up to 10 weeks
Primary	Area under plasma concentration-time curve from 0 to infinity (AUCinf) for vadadustat		Up to 10 weeks
Primary	Maximum observed plasma concentration (Cmax) for vadadustat		Up to 10 weeks
Secondary	Time to maximum observed plasma concentration (Tmax) of vadadustat		Up to 10 weeks
Secondary	Elimination rate constant (Kel) of vadadustat		Up to 10 weeks
Secondary	Terminal half-life (t½) of vadadustat		Up to 10 weeks
Secondary	Apparent total body clearance (CL/F) of vadadustat		Up to 10 weeks
Secondary	Percent of extrapolated area under the curve from time t to infinity (%AUCextrap) of vadadustat		Baseline and end of study
Secondary	Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of vadadustat-O-glucuronide		Up to 10 weeks
Secondary	Area under plasma concentration-time curve from 0 to infinity (AUCinf) of vadadustat-O-glucuronide		Up to 10 weeks
Secondary	Maximum observed plasma concentration (Cmax) of vadadustat-O-glucuronide		Up to 10 weeks
Secondary	Reporting of treatment emergent adverse event (TEAE) as reported by study subjects		Up to 10 weeks