Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800173
Other study ID # BCX4430-106
Secondary ID DMID18-001327220
Status Completed
Phase Phase 1
First received
Last updated
Start date December 10, 2018
Est. completion date April 30, 2019

Study information

Verified date July 2021
Source BioCryst Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
galidesivir
galidesivir IV infusion
placebo
placebo IV infusion

Locations

Country Name City State
United States PRA Health Sciences Lenexa Kansas

Sponsors (2)

Lead Sponsor Collaborator
BioCryst Pharmaceuticals National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

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.
See also
  Status Clinical Trial Phase
Completed NCT03475056 - cAd3-Marburg Vaccine in Healthy Adults Phase 1
Active, not recruiting NCT05817422 - Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults Phase 2
Completed NCT04723602 - Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults Phase 1
Completed NCT00605514 - Ebola and Marburg Virus Vaccines Phase 1
Recruiting NCT06265012 - Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects Phase 1
Completed NCT00997607 - Evaluating an Ebola and a Marburg Vaccine in Uganda Phase 1