NCT03801746

Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin

A Phase 1, Two-Part, Open-label Study in Healthy Adult Volunteers to Assess a Single Dose of Vadadustat as a Victim in Drug-Drug Interactions With Cyclosporine, Probenecid and Rifampin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects.

Detailed description

This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects. Part 1 consists of 2 arms (cyclosporine and probenecid) and Part 2 consists of 1 arm (rifampin). Twenty (20) unique subjects will be enrolled into each study arm. The PK and safety/tolerability data from Part 1 Arm 1 (cyclosporine) will determine if Part 2 (rifampin) will proceed. Subjects will be on study for up to 72 days, including a 28-day screening period, 6-10 day clinic period, and a 30-day follow-up period post last dose. Blood and/or urine samples for PK analysis will be collected at pre-defined timepoints throughout the study.

Conditions

• Drug Interaction Potentiation

Interventions

Type	Name	Description
DRUG	vadadustat	Oral dose 300 mg
DRUG	Rifampin	IV Rifampin
DRUG	Probenecid	Oral Probenecid
DRUG	Cyclosporins	Oral Cyclosporine

Timeline

• Start date: 2018-07-20
• Primary completion: 2018-08-15
• Completion: 2018-08-15
• First posted: 2019-01-11
• Last updated: 2019-03-22

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study