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Completed

NCT Number: NCT01790087

ANX-188 Thorough QT/QTc Study 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)

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Baltimore, Maryland, 20201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANX-188 Therapeutic Dose

Drug

Other names: vepoloxamer

ANX-188 Supratherapeutic dose

Drug

Other names: vepoloxamer

Saline

Drug

Other names: Placebo Comparator

moxifloxacin

Drug

Other names: Active Comparator

Primary outcomes

  1. 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

Secondary outcomes

  1. Bazett's corrected QT-interval (QTcB)

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

  2. Heart rate measurements on treatment compared to time-matched baseline and placebo

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

  3. RR-interval on treatment compared to time-matched baseline and placebo

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

  4. QRS measurements on treatment compared to time-matched baseline and placebo

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

  5. PR interval measurements on treatment compared to time-matched baseline and placebo

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

  6. Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs

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

  7. Number and percentage of subjects that develop abnormalities of repolarization on treatment

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

  8. Number and percentage of subjects the develop abnormal U waves

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

  9. Relationship between changes from the baseline and placebo in QTcF (DDQTcF)

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

  10. Analysis for arrhythmias

    Time frame: Pre-dose to 24 hours post-dsoe

  11. Correlation of ECG findings with clinical adverse events

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

Sponsors and collaborators

Lead sponsor

Mast Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2013
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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