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

Phase 1CompletedNCT03083821

Bristol-Myers Squibb6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B Virus

Interventions

BaracludeDRUG

Specified dose on specified day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Local Institution

Hachioji-shi, Tokyo, Japan

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Cmax is defined as the peak plasma concentration

Time frame: Up to 24 hours

Time of Maximum Observed Plasma Concentration (Tmax)

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

Time frame: Up to 24 hours

Trough Observed Plasma (Predose) Concentration (Ctrough)

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

Time frame: prior to administration of drug (predose)

Observed Plasma Concentration at 24 Hours Postdose (C24)

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

Time frame: 24 hours post-dose

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

Time frame: Up to 24 hours

Apparent Total Body Clearance (CLT/F)

CLT/F is defined as the apparent total body clearance

Time frame: Up to 24 hours

Data from ClinicalTrials.gov

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