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galidesivir

Phase 1

Marburg Virus Disease | Small molecule | Infectious Disease |BioCryst Pharmaceuticals, Inc.|Last Updated: Jul 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

galidesivir · 1 trial · 1 indication

Phase 1 1
NCT03800173A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430Marburg Virus Disease
COMPLETED32 Analytics
PHASE1COMPLETED
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
Marburg Virus Disease
NCT0380017332
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Study Endpoints

Primary Endpoints

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

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GalidesivirEXPERIMENTALGalidesivir IV infusion
placeboPLACEBO_COMPARATORPlacebo IV infusion

Interventions

NameTypeDescription
galidesivirDRUGgalidesivir IV infusion
placeboDRUGplacebo IV infusion
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 conditio...

Countries:United States
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Frequently asked questions about galidesivir

What is galidesivir used for?

Galidesivir is an investigational small molecule being developed for Marburg Virus Disease. It is currently in Phase 1 clinical development and is not yet approved. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy volunteers.

What does galidesivir target?

Galidesivir is a small molecule antiviral. Its specific molecular target has not been disclosed in the available information. The drug is being evaluated for its potential to treat Marburg Virus Disease, a viral hemorrhagic fever.

Who makes galidesivir?

Galidesivir is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol BCRX. The company is conducting clinical trials to evaluate the drug's safety and tolerability.

What phase is galidesivir in?

Galidesivir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is galidesivir in?

Galidesivir has been studied in one completed Phase 1 clinical trial, identified as NCT03800173. This trial evaluated the single-dose safety, tolerability, and pharmacokinetics of intravenous BCX4430 in healthy volunteers in the United States. The trial enrolled 32 participants.

Is galidesivir the same as BCX4430?

Yes, galidesivir is also known as BCX4430. The clinical trial NCT03800173, which evaluated the drug's safety and pharmacokinetics, used the name BCX4430 in its title. Both names refer to the same investigational compound.