NCT02508753

Safety Study Designed to Study the Effects of Two Different Doses of CXA-101/Tazobactam, a Low Dose and a High Dose, on the QT/QTc Intervals in Healthy Subjects

A Double-Blind, Double-Dummy, Randomized, Moxifloxacin and Placebo Controlled, Four-Way Crossover Study of the Effects of a Single Intravenous Supra-Therapeutic Dose and Single Intravenous Therapeutic Dose of CXA-101/Tazobactam on the QT/QTC Intervals in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is look at the possible side effects of two different doses of CXA-101/tazobactam, a low dose and a high dose, on participant's heart.

Detailed description

Some drugs can have effects on the cardiovascular system (hearts and blood vessels) including the QT interval. The QT interval is the time between the contraction and relaxation of the chambers of the heart, called ventricles, which collect and pump blood. The use of some drugs can lead to serious issues such as QT interval prolongation (lengthen) and potentially serious arrhythmias (abnormal heart beat), and sudden death. Therefore, it is important to study effect of medications on the heart. The drug, Moxifloxacin, will be introduced as a control to be able to compare the effect, if any, that CXA 101/tazobactam might have on participant's heart.Moxifloxacin is an approved antibiotic commonly used to treat common bacterial infections. Moxifloxacin is known to slightly increase the electrical conduction of participant's heart.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CXA-101/tazobactam	1000/500 mg single IV dose administered over 60 minutes
DRUG	CXA-101/tazobactam	3000/1500 mg single IV dose administered over 60 minutes
DRUG	Moxifloxacin	400 mg tablet
DRUG	placebo	single IV dose of a saline solution administered over 60 minutes plus oral over-encapsulated moxifloxacin placebo tablet administered at the start of infusion.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2015-07-27
• Last updated: 2017-01-26

Locations

1 site across 1 country: United States