NCT03789032

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Drug Interaction Potentiation
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Vadadustat	Vadadustat 300 mg
DRUG	Rabeprazole	Oral Rabeprazole

Timeline

• Start date: 2018-10-03
• Primary completion: 2018-11-09
• Completion: 2018-11-19
• First posted: 2018-12-28
• Last updated: 2019-03-22

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study