NCT02062203

Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

A Phase 1, Single-Center, Partially Double-Blinded, Active and Placebo Controlled, Randomized 4-Way Crossover Study to Evaluate the Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AKB-6548 (therapeutic dose)	Single oral dose of AKB-6548 at a therapeutic dose level
DRUG	AKB-6548 (supratherapeutic dose)	Single oral dose of AKB-6548 at a supratherapeutic dose level
DRUG	Placebo	Single oral dose of placebo
DRUG	Moxifloxacin	Single oral dose of 400 mg moxifloxacin

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-02-13
• Last updated: 2018-11-14

Locations

1 site across 1 country: United States