ANX-188 Thorough QT/QTc Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ANX-188 Therapeutic Dose; Drug: ANX-188 Supratherapeutic dose; Drug: Saline; Drug: Moxifloxacin

• Registration Number: NCT01790087
• Lead Sponsor: Mast Therapeutics, Inc.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ANX-188 Therapeutic dose level	ANX-188 Therapeutic Dose	IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours
ANX-188 Supratherapeutic dose	ANX-188 Supratherapeutic dose	IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours
Saline	Saline	IV administration. Six hour infusion.
Moxifloxacin	Moxifloxacin	Oral tablet. 400 mg.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Baltimore, Maryland, United States