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

NCT03801759 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-03-22

No results posted yet for this study

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.

Conditions

  • Drug Interaction Potentiation

Interventions

DRUG

Vadadustat

Oral dose 600 mg

DRUG

Furosemide

Oral Furosemide

DRUG

Adefovir

Oral Adefovir

DRUG

Digoxin

Oral Digoxin

Sponsors & Collaborators

  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Akebia Therapeutics · Sponsor GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-20
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03801759 on ClinicalTrials.gov