NCT03801759

Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

A Phase 1 Open-label, Three Arm Study in Healthy Adult Volunteers to Assess Vadadustat as a Perpetrator in Drug-Drug-Interactions With Digoxin, Adefovir and Furosemide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects.

Detailed description

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects. Unique subjects will be enrolled into each arm of the study and enrollment will be sequential. The first 20 subjects confirmed to be eligible will be assigned to Arm 1 (digoxin), the next 16 subjects will be assigned to Arm 2 (adefovir) and the next 22 subjects will be assigned to Arm 3 (furosemide). Blood samples for PK analysis will be collected at pre-defined timepoints for each arm throughout the study. Subjects will be on study for up to 80 days, including a 28-day screening period, 7-21 day in clinic period, and a 30-day follow up period post last dose.

Conditions

• Drug Interaction Potentiation

Interventions

Type	Name	Description
DRUG	Vadadustat	Oral dose 600 mg
DRUG	Furosemide	Oral Furosemide
DRUG	Adefovir	Oral Adefovir
DRUG	Digoxin	Oral Digoxin

Timeline

• Start date: 2018-07-20
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2019-01-11
• Last updated: 2019-03-22

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study