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Baraclude

Phase 1

Hepatitis B Virus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Nov 18, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Baraclude · 1 trial · 1 indication

Phase 1 1
NCT03083821A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical SettingHepatitis B Virus
COMPLETED6 Analytics
PHASE1COMPLETED
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
Hepatitis B VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Up to 24 hours

Cmax is defined as the peak plasma concentration

Time of Maximum Observed Plasma Concentration (Tmax)
Up to 24 hours

Tmax is defined as the time of maximum observed plasma concentration, measured in hours

Trough Observed Plasma (Predose) Concentration (Ctrough)
prior to administration of drug (predose)

Ctrough is defined as the trough in observed plasma (predose) concentrations

Observed Plasma Concentration at 24 Hours Postdose (C24)
24 hours post-dose

C24 is defined as the observed plasma concentration at 24 hours post-dose

Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]
Up to 24 hours

AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval

Apparent Total Body Clearance (CLT/F)
Up to 24 hours

CLT/F is defined as the apparent total body clearance

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -

Interventions

NameTypeDescription
BaracludeDRUGSpecified dose on specified day
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Eligibility Criteria

Age Range20 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. * Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB. * Participants who are being...

Countries:Japan
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Frequently asked questions about Baraclude

What is Baraclude used for?

Baraclude is used for the treatment of Hepatitis B Virus infection. It is a small molecule therapeutic being developed in the infectious disease area. The drug is currently in Phase 1 clinical development, with studies conducted to better understand its pharmacokinetic properties in a real world clinical setting.

Who makes Baraclude?

Baraclude is developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this small molecule drug for Hepatitis B Virus infection, with a completed Phase 1 study in Japan.

What phase is Baraclude in?

Baraclude is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 study has been completed, which enrolled 6 participants with Hepatitis B Virus in Japan to evaluate the drug's pharmacokinetic properties.

What clinical trials is Baraclude in?

Baraclude has one completed clinical trial registered as NCT03083821, titled "A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting." This Phase 1 study enrolled 6 participants with Hepatitis B Virus in Japan, with a minimum age of 20 years.

How does Baraclude work?

Baraclude is a small molecule therapeutic being studied for Hepatitis B Virus infection. The specific molecular target of Baraclude has not been disclosed in the available clinical trial information. The completed Phase 1 study focused on understanding its pharmacokinetic properties in a real world clinical setting.