ANX-188 Thorough QT/QTc Study in Healthy Volunteers

A Four Period, Four-Arm, Crossover Design, Randomized, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Single-Dose ANX-188 on the QT/QTc Intervals in Healthy Volunteers

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Saline; Drug: Moxifloxacin; Drug: ANX-188 Therapeutic Dose; Drug: ANX-188 Supratherapeutic dose

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 20201
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ANX-188 Therapeutic dose level; IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours	Drug: ANX-188 Therapeutic Dose; Other Names: vepoloxamer
EXPERIMENTAL: ANX-188 Supratherapeutic dose; IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours	Drug: ANX-188 Supratherapeutic dose; Other Names: vepoloxamer
PLACEBO_COMPARATOR: Saline; IV administration. Six hour infusion.	Drug: Saline; Other Names: Placebo Comparator
ACTIVE_COMPARATOR: Moxifloxacin; Oral tablet. 400 mg.	Drug: Moxifloxacin; Other Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)	Day 1 Pre-dose to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Bazett's corrected QT-interval (QTcB)	Pre-dose to 24 hours post-dose
Heart rate measurements on treatment compared to time-matched baseline and placebo	Pre-dose to 24 hours post-dose
RR-interval on treatment compared to time-matched baseline and placebo	Pre-dose to 24 hours post-dose
QRS measurements on treatment compared to time-matched baseline and placebo	Pre-dose to 24 hours post-dose
PR interval measurements on treatment compared to time-matched baseline and placebo	Pre-dose to 24 hours post-dose
Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs	Pre-dose to 24 hours post-dose
Number and percentage of subjects that develop abnormalities of repolarization on treatment	Pre-dose to 24 hours post-dose
Number and percentage of subjects the develop abnormal U waves	Pre-dose to 24 hours post-dose
Relationship between changes from the baseline and placebo in QTcF (DDQTcF)	Pre-dose to 24 hours post-dose
Analysis for arrhythmias	Pre-dose to 24 hours post-dsoe
Correlation of ECG findings with clinical adverse events	Pre-dose to 24 hours post-dose

Collaborators and Investigators

• Sponsor: Mast Therapeutics, Inc.
• Investigators: Study Director: Edwin L Parsley, D.O., Mast Therapeutics

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: ANX-188-05