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

NCT03800173 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: BCX4430-106DMID18-0013272201300017C-18-0-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Marburg Virus Disease

Outcome Measures

Primary Outcomes (1)

• Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.

  Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).

  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 (3)

• Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)

  Plasma PK parameters are based on sampling over a 21 day period

• Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)

  Plasma PK parameters are based on sampling over a 21 day period

• Galidesivir Renal Clearance

  Urine PK parameters are based on sampling over a 96 hour period.

Study Arms (2)

Galidesivir

EXPERIMENTAL

Galidesivir IV infusion

Drug: galidesivir

placebo

PLACEBO COMPARATOR

Placebo IV infusion

Drug: placebo

Interventions

galidesivir DRUG

galidesivir IV infusion

Galidesivir

placebo DRUG

placebo IV infusion

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

• 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.

  PMID: 35182042 DERIVED

MeSH Terms

Conditions

Marburg Virus Disease

Interventions

galidesivir

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; Monkey Diseases; Primate Diseases; Animal Diseases

Results Point of Contact

• Title: Study Director
• Organization: BioCryst Pharmaceuticals Inc

clinicaltrials@biocryst.com

+1 919-859-1302

Study Officials

• Daniel Dickerson, MD, PhD

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 11, 2019
• Study Start: December 10, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: July 23, 2021
• Results First Posted: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)