A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430 (NCT03800173) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
United States32 participantsStarted 2018-12-10
Plain-language summary
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* written informed consent
* males and non-pregnant, non-lactating females
* BMI 19.0-32.0
* willing to abide by contraceptive requirements
* normal vitals
* willing to abide by study procedures and restrictions
Exclusion Criteria:
* 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
What they're measuring
1
Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Timeframe: AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.