Lenexa, Kansas 66219


Purpose:

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


Study summary:

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 cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo.


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


NCT ID:

NCT03800173


Primary Contact:

Principal Investigator
Daniel Dickerson, MD, PhD
PRA Health Sciences

Study Director
Phone: 919-859-1302
Email: clinicaltrials@biocryst.com


Backup Contact:

N/A


Location Contact:

Lenexa, Kansas 66219
United States

Recruitment Center

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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