ANX-188 Thorough QT/QTc Study in Healthy Volunteers

NCT01790087 | Completed Phase 1 DMC

• 1 other identifier: ANX-188-05
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (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 Outcomes (11)

• 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

• PR interval measurements on treatment compared to time-matched baseline and placebo

  Pre-dose to 24 hours post-dose

Study Arms (4)

ANX-188 Therapeutic dose level

EXPERIMENTAL

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

Drug: ANX-188 Therapeutic Dose

ANX-188 Supratherapeutic dose

EXPERIMENTAL

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

Drug: ANX-188 Supratherapeutic dose

Saline

PLACEBO COMPARATOR

IV administration. Six hour infusion.

Drug: Saline

Moxifloxacin

ACTIVE COMPARATOR

Oral tablet. 400 mg.

Drug: Moxifloxacin

Interventions

ANX-188 Therapeutic Dose DRUG

Also known as: vepoloxamer

ANX-188 Therapeutic dose level

ANX-188 Supratherapeutic dose DRUG

Also known as: vepoloxamer

ANX-188 Supratherapeutic dose

Saline DRUG

Also known as: Placebo Comparator

Saline

Moxifloxacin DRUG

Also known as: Active Comparator

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mast Therapeutics, Inc.: lead

Study Sites (1)

Research Site

Baltimore, Maryland, 20201, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Moxifloxacin

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Edwin L Parsley, D.O.

  Mast Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (1)