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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790087

Enrollment

Registered

2013-02-13

Start date

2013-02-28

Completion date

2013-06-30

Last updated

2015-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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)

Interventions

DRUGANX-188 Therapeutic Dose

DRUGANX-188 Supratherapeutic dose

DRUGSaline

DRUGMoxifloxacin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

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

Measure	Time frame
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
Bazett's corrected QT-interval (QTcB)	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
Number and percentage of subjects that develop abnormalities of repolarization on treatment	Pre-dose to 24 hours post-dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026