ANX-188 Thorough QT/QTc Study in Healthy Volunteers

Mast Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Saline; Drug: ANX-188 Therapeutic Dose; Drug: Moxifloxacin; Drug: ANX-188 Supratherapeutic dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01790087

ANX-188-05

Details and patient eligibility

About

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)

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 4 patient groups, including a placebo group

ANX-188 Therapeutic dose level

Experimental group

Description:

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

Treatment:

Drug: ANX-188 Therapeutic Dose

ANX-188 Supratherapeutic dose

Experimental group

Description:

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

Treatment:

Drug: ANX-188 Supratherapeutic dose

Saline

Placebo Comparator group

Description:

IV administration. Six hour infusion.

Treatment:

Drug: Saline

Moxifloxacin

Active Comparator group

Description:

Oral tablet. 400 mg.

Treatment:

Drug: Moxifloxacin