ANX-188 Thorough QT/QTc Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mast Therapeutics, Inc.
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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