Phase 1
Completed N=32
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Marburg Virus Disease
Source: ClinicalTrials.gov NCT03800173 ↗
Enrolled (actual)
32
Serious AEs
6.3%
Results posted
Jul 2021
Primary outcomePrimary: Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. — 2; 0; 1; 4 participants
Summary
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. |
2; 0; 1; 4; 1; 2 | — |
| SECONDARY Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug) |
5540; 10300; 17730; 20490 | — |
| SECONDARY Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve) |
21160; 37080; 65860; 81230; 17150; 32360 | — |
| SECONDARY Galidesivir Renal Clearance |
9.305; 11.66; 11.51; 7.131 | — |
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
Data sourced from ClinicalTrials.gov (NCT03800173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.