ANX-188 Thorough QT/QTc Study in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval (QTcF)

Key facts

Study ID

NCT01790087

Run by

Mast Therapeutics, Inc.

People needed

72

Starts

2013-02-01

Expected to finish

2013-06-01

Last updated by the study team

2015-05-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female subjects aged 18 to 65 (inclusive) in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory testing at screening.

You may not qualify if…

• Participation in a clinical trial within the last 60 days
• Pregnant or lactating females
• Use of prescription drugs, herbals, or over-the-counter medications within 14 days prior to study day -2
• Uncontrolled cardiac arrhythmias, cardiac valve abnormalities, or not in normal sinus rhythm
• Smokers or tobacco product user in the prior 3 months
• Presence of clinically significant illness
• Other protocol defined inclusion/exclusion criteria may apply

Where it is running

• Research Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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