ANX-188 Thorough QT/QTc Study in Healthy Volunteers

Mast Therapeutics, Inc.72 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

ANX-188 Therapeutic DoseDRUG

ANX-188 Supratherapeutic doseDRUG

SalineDRUG

MoxifloxacinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)

Time frame: Day 1 Pre-dose to 24 hours post-dose