A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting

Hepatitis B Virus Clinical Trial

Official title:

A Clinical Study to Evaluate the Steady State Pharmacokinetics of Baraclude in Participants With Hepatitis B Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083821
• Other study ID #: AI463-528
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2017
• Est. completion date: December 19, 2017

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment.
• Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2)

Exclusion Criteria:

• Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug.
• Any gastrointestinal surgery that could impact upon the absorption of study drug.
• Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only). Other protocol defined inclusion/exclusion criteria could apply.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B Virus

Intervention

Drug:
• Baraclude
Specified dose on specified day

Locations

Country	Name	City	State
Japan	Local Institution	Hachioji-shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax is defined as the peak plasma concentration	Up to 24 hours
Primary	Time of Maximum Observed Plasma Concentration (Tmax)	Tmax is defined as the time of maximum observed plasma concentration, measured in hours	Up to 24 hours
Primary	Trough Observed Plasma (Predose) Concentration (Ctrough)	Ctrough is defined as the trough in observed plasma (predose) concentrations	prior to administration of drug (predose)
Primary	Observed Plasma Concentration at 24 Hours Postdose (C24)	C24 is defined as the observed plasma concentration at 24 hours post-dose	24 hours post-dose
Primary	Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]	AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval	Up to 24 hours
Primary	Apparent Total Body Clearance (CLT/F)	CLT/F is defined as the apparent total body clearance	Up to 24 hours

External Links

•   BMS Clinical Trial Patient Recruiting