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Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

NCT03801733 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2019-03-22

No results posted yet for this study

Summary

This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and simvastatin in healthy male and female subjects.

Conditions

  • Drug Interaction Potentiation

Interventions

DRUG

Vadadustat

Oral dose of 600 mg QD

DRUG

Simvastatin

Oral Simvastatin

DRUG

Rosuvastatin

Oral Rosuvastatin

DRUG

Atorvastatin

Oral Atorvastatin

DRUG

Pravastatin

Oral Pravastatin

DRUG

Sulfasalazine

Oral Sulfasalazine

Sponsors & Collaborators

  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Akebia Inc · Akebia Therapeutics

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
2018-06-17
Primary Completion
2018-11-24
Completion
2018-11-24
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 NCT03801733 on ClinicalTrials.gov