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

BioCryst

Status and phase: Completed; Phase 1

Conditions: Marburg Virus Disease

Treatments: Drug: galidesivir; Drug: placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03800173

272201300017C-18-0-1 (U.S. NIH Grant/Contract)

BCX4430-106

DMID18-0013 (Other Identifier)

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Galidesivir

Experimental group

Description:

Galidesivir IV infusion

Treatment:

Drug: galidesivir

placebo

Placebo Comparator group

Description:

Placebo IV infusion

Treatment:

Drug: placebo