NCT03657290

A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet

A Randomized, Open-Label, Single-Dose, Three-Period Six-Sequence Crossover Study in Healthy Adults to Assess Bioequivalence Between Test and Reference Vadadustat 450 mg and 150 mg Tablets and to Determine Food Effect on the 450 mg Vadadustat Tablet.

• 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 is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.

Detailed description

This is a randomized, open-label, single-dose, three-period crossover study in healthy adults to assess the bioequivalence of 3 X 150 mg vadadustat tablets (Test) compared to a single 450 mg vadadustat tablet (reference). Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose. The study will also assess the effect of food on vadadustat bioavailability by evaluating the pharmacokinetics of the 450 mg tablet in fed and fasted subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	vadadustat	Vadadustat Tablets

Timeline

• Start date: 2018-08-03
• Primary completion: 2018-10-16
• Completion: 2018-10-16
• First posted: 2018-09-05
• Last updated: 2019-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study