ANX-188 Thorough QT/QTc Study in Healthy Volunteers

NCT ID: NCT01790087

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ANX-188 Therapeutic dose level

IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours

Group Type EXPERIMENTAL

ANX-188 Therapeutic Dose

Intervention Type DRUG

ANX-188 Supratherapeutic dose

IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours

Group Type EXPERIMENTAL

ANX-188 Supratherapeutic dose

Intervention Type DRUG

Saline

IV administration. Six hour infusion.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Moxifloxacin

Oral tablet. 400 mg.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Interventions

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ANX-188 Therapeutic Dose

Intervention Type DRUG

ANX-188 Supratherapeutic dose

Intervention Type DRUG

Saline

Intervention Type DRUG

Moxifloxacin

Intervention Type DRUG

Other Intervention Names

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vepoloxamer vepoloxamer Placebo Comparator Active Comparator

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mast Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin L Parsley, D.O.

Role: STUDY_DIRECTOR

Mast Therapeutics

Locations

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Research Site

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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ANX-188-05

Identifier Type: -

Identifier Source: org_study_id

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