A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BioCryst Pharmaceuticals
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Galidesivir

Criteria

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