Marburg Virus Disease Clinical Trial
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
Verified date | July 2021 |
Source | BioCryst Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
Status | Completed |
Enrollment | 32 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | PRA Health Sciences | Lenexa | Kansas |
Lead Sponsor | Collaborator |
---|---|
BioCryst Pharmaceuticals | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug) | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day) Day 21 (+2 days) or early termination. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Plasma PK parameters are based on sampling over a 21 day period | |
Secondary | Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day) Day 21 (+2 days) or early termination. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Plasma PK parameters are based on sampling over a 21 day period | |
Secondary | Galidesivir Renal Clearance | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. | Urine PK parameters are based on sampling over a 96 hour period. |
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