ANX-188 Thorough QT/QTc Study in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/30/2013 |
| Start Date: | February 2013 |
| End Date: | June 2013 |
| Contact: | Adventrx CT.gov Call Center |
| Phone: | 1-888-965-1238 |
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
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)
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
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