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ANX-188 Thorough QT/QTc Study in Healthy Volunteers

Sponsor
Mast Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01790087
Collaborator
(none)
72
Enrollment
1
Location
4
Arms
3.9
Duration (Months)
18.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official 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
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Bazett's corrected QT-interval (QTcB) [Pre-dose to 24 hours post-dose]

    2. Heart rate measurements on treatment compared to time-matched baseline and placebo [Pre-dose to 24 hours post-dose]

    3. RR-interval on treatment compared to time-matched baseline and placebo [Pre-dose to 24 hours post-dose]

    4. QRS measurements on treatment compared to time-matched baseline and placebo [Pre-dose to 24 hours post-dose]

    5. PR interval measurements on treatment compared to time-matched baseline and placebo [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 [Pre-dose to 24 hours post-dose]

    7. Number and percentage of subjects that develop abnormalities of repolarization on treatment [Pre-dose to 24 hours post-dose]

    8. Number and percentage of subjects the develop abnormal U waves [Pre-dose to 24 hours post-dose]

    9. Relationship between changes from the baseline and placebo in QTcF (DDQTcF) [Pre-dose to 24 hours post-dose]

    10. Analysis for arrhythmias [Pre-dose to 24 hours post-dsoe]

    11. Correlation of ECG findings with clinical adverse events [Pre-dose to 24 hours post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Baltimore Maryland United States 20201

    Sponsors and Collaborators

    • Mast Therapeutics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mast Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01790087
    Other Study ID Numbers:
    • ANX-188-05
    First Posted:
    Feb 13, 2013
    Last Update Posted:
    May 20, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Moxifloxacin

    Study Results

    No Results Posted as of May 20, 2015