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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03800173
Recruitment Status : Completed
First Posted : January 11, 2019
Results First Posted : July 23, 2021
Last Update Posted : July 23, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Marburg Virus Disease Drug: galidesivir Drug: placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Galidesivir
Galidesivir IV infusion
Drug: galidesivir
galidesivir IV infusion

Placebo Comparator: placebo
Placebo IV infusion
Drug: placebo
placebo IV infusion




Primary Outcome Measures :
  1. Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. [ Time Frame: 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. ]
    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).


Secondary Outcome Measures :
  1. Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug) [ Time Frame: Plasma PK parameters are based on sampling over a 21 day period ]

    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.).


  2. Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve) [ Time Frame: Plasma PK parameters are based on sampling over a 21 day period ]

    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.).


  3. Galidesivir Renal Clearance [ Time Frame: Urine PK parameters are based on sampling over a 96 hour period. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800173


Locations
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United States, Kansas
PRA Health Sciences
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
BioCryst Pharmaceuticals
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Daniel Dickerson, MD, PhD PRA Health Sciences
  Study Documents (Full-Text)

Documents provided by BioCryst Pharmaceuticals:
Study Protocol  [PDF] January 11, 2019
Statistical Analysis Plan  [PDF] April 10, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03800173    
Other Study ID Numbers: BCX4430-106
DMID18-0013 ( Other Identifier: NIAID )
272201300017C-18-0-1 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2019    Key Record Dates
Results First Posted: July 23, 2021
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Marburg Virus Disease
Infections
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Galidesivir
Antiviral Agents
Anti-Infective Agents