NCT02412449

Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

A Randomized, Open-Label, Single-Dose, Three-Period Crossover Study in Healthy Adults to Assess the Relative Bioavailability of Test and Reference Formulations of AKB-6548 Tablets and to Evaluate the Effect of Food on the Bioavailability of AKB-6548

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

Summary

The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AKB-6548 tablet, reference formulation given in the fasted state
DRUG	AKB-6548 tablet, test formulation given in the fasted state.
DRUG	AKB-6548 tablet, test formulation given in the fed state

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-04-09
• Last updated: 2018-11-14

Locations

1 site across 1 country: United States