Clinical trial NCT03800173: A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Official title: A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Marburg Virus Disease
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-01-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)
timeFrame: Plasma PK parameters are based on sampling over a 21 day period
measure: Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)
timeFrame: Plasma PK parameters are based on sampling over a 21 day period
measure: Galidesivir Renal Clearance
timeFrame: Urine PK parameters are based on sampling over a 96 hour period.
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences
state: Kansas
Study officials:
affiliation: PRA Health Sciences
name: Daniel Dickerson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19.