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

NCT03801746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-22

No results posted yet for this study

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.

Conditions

  • Drug Interaction Potentiation

Interventions

DRUG

vadadustat

Oral dose 300 mg

DRUG

Rifampin

IV Rifampin

DRUG

Probenecid

Oral Probenecid

DRUG

Cyclosporins

Oral Cyclosporine

Sponsors & Collaborators

  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Akebia Inc · Sponsor GmbH

Study Design

Allocation
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
2018-08-15
Completion
2018-08-15
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT03801746 on ClinicalTrials.gov