Status:
COMPLETED
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Lead Sponsor:
BioCryst Pharmaceuticals
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Marburg Virus Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
Detailed Description
This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03800173
Start Date
December 10 2018
End Date
April 30 2019
Last Update
July 23 2021
Active Locations (1)
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1
PRA Health Sciences
Lenexa, Kansas, United States, 66219