NCT03801733

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

A Phase 1, Three-Part, Open-label Study in Healthy Adult Volunteers to Assess Vadadustat as a Perpetrator in Drug-Drug Interactions With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Thirty-four (34) subjects will be enrolled in Part 1 (rosuvastatin) and based on review of the PK and safety/tolerability data, a decision will be made on whether to proceed with Part 2. Part 2 consists of 2 arms (sulfasalazine and pravastatin). Twenty-six (26) subjects will be enrolled into each arm. Part 3 consists of 2 arms (atorvastatin and simvastatin). Twenty-four (24) subjects will be enrolled into each arm after enrollment in Part 2 is completed. Subjects will be in the study for up to 72 days, including a 28-day screening period, 6-14 day in clinic period, and a 30-day follow up period post last dose. Blood samples for PK analysis will be collected at pre-defined time points throughout the study.

Conditions

• Drug Interaction Potentiation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-17
• Primary completion: 2018-11-24
• Completion: 2018-11-24
• First posted: 2019-01-11
• Last updated: 2019-03-22

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study