A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Completed · Phase 1 · Has a placebo group
Conditions studied: Marburg Virus Disease
In brief
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
Key facts
- Study ID
- NCT03800173
- Run by
- BioCryst Pharmaceuticals
- People needed
- 32
- Starts
- 2018-12-10
- Expected to finish
- 2019-04-30
- Last updated by the study team
- 2021-07-23
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition
- abnormal cardiac finding, or laboratory/urinalysis abnormality at screening
- known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention
- current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit
- use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study
- Recent or current history of alcohol or drug abuse
- Regular use of tobacco or nicotine products
- Positive serology for HBV, HCV, or HIV
- history of severe adverse reaction to or known sensitivity to any drug
- pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded
Where it is running
- PRA Health Sciences — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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