NCT04299633

Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat

A Phase 1, Three-Part, Open-Label Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This 3-part study will be conducted to evaluate the interaction of vadadustat with sevelamer carbonate, calcium acetate, and Auryxia in healthy male and female participants. A total of 18 participants will be enrolled in each part of the study. Part 1 of the study will be conducted to assess the effect of a single oral dose of sevelamer carbonate (1600 milligrams \[mg\]) on the pharmacokinetics (PK) of a single oral dose of vadadustat (300 mg). Part 2 of the study will be conducted to assess the effect of a single oral dose of calcium acetate (1334 mg) on the PK of a single oral dose of vadadustat (300 mg). Part 3 of the study will be conducted to assess the effect of a single oral dose of Auryxia® (2 grams) on the PK of a single oral dose of vadadustat (300 mg).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Vadadustat	2 x 150 mg oral tablets
DRUG	Sevelamer carbonate	2 x 800 mg oral tablets
DRUG	Calcium acetate	2 x 667 mg oral gelcaps
DRUG	Auryxia®	2 x 1 gram tablets (210 mg ferric iron equivalent to 1000 mg ferric citrate)

Timeline

• Start date: 2020-06-15
• Primary completion: 2020-08-02
• Completion: 2020-09-28
• First posted: 2020-03-09
• Last updated: 2020-10-08

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study