Clinical trial NCT01790087: ANX-188 Thorough QT/QTc Study in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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)


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)
timeFrame: Day 1 Pre-dose to 24 hours post-dose
Secondary outcomes:
measure: Bazett's corrected QT-interval (QTcB)
timeFrame: Pre-dose to 24 hours post-dose
measure: Heart rate measurements on treatment compared to time-matched baseline and placebo
timeFrame: Pre-dose to 24 hours post-dose
measure: RR-interval on treatment compared to time-matched baseline and placebo
timeFrame: Pre-dose to 24 hours post-dose
measure: QRS measurements on treatment compared to time-matched baseline and placebo
timeFrame: Pre-dose to 24 hours post-dose
measure: PR interval measurements on treatment compared to time-matched baseline and placebo
timeFrame: Pre-dose to 24 hours post-dose
measure: Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs
timeFrame: Pre-dose to 24 hours post-dose
measure: Number and percentage of subjects that develop abnormalities of repolarization on treatment
timeFrame: Pre-dose to 24 hours post-dose
measure: Number and percentage of subjects the develop abnormal U waves
timeFrame: Pre-dose to 24 hours post-dose
measure: Relationship between changes from the baseline and placebo in QTcF (DDQTcF)
timeFrame: Pre-dose to 24 hours post-dose
measure: Analysis for arrhythmias
timeFrame: Pre-dose to 24 hours post-dsoe
measure: Correlation of ECG findings with clinical adverse events
timeFrame: Pre-dose to 24 hours post-dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: Mast Therapeutics
name: Edwin L Parsley, D.O.
role: STUDY_DIRECTOR
References: