Hepatitis B Virus
Conditions
Brief summary
A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
Interventions
DRUGBaraclude
Specified dose on specified day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baraclude Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Baraclude |
|---|---|
| Age, Continuous | 55.0 Years STANDARD_DEVIATION 9.96 |
| Race/Ethnicity, Customized | 6 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Apparent Total Body Clearance (CLT/F)
CLT/F is defined as the apparent total body clearance
Time frame: Up to 24 hours
Population: All treated participants with available pharmacokinetics data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baraclude | Apparent Total Body Clearance (CLT/F) | 397 mL/min | Standard Deviation 81.7 |
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
Time frame: Up to 24 hours
Population: All treated participants with available pharmacokinetics data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baraclude | Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] | 21.8 h*ng/mL | Standard Deviation 4.53 |
Primary
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the peak plasma concentration
Time frame: Up to 24 hours
Population: All treated participants with available pharmacokinetics data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baraclude | Maximum Observed Plasma Concentration (Cmax) | 8.17 ng/mL | Standard Deviation 2.517 |
Primary
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
Population: All treated participants with available pharmacokinetics data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baraclude | Observed Plasma Concentration at 24 Hours Postdose (C24) | 0.435 ng/mL | Standard Deviation 0.0678 |
Primary
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
Population: All treated participants with available pharmacokinetics data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baraclude | Time of Maximum Observed Plasma Concentration (Tmax) | 0.667 Hours | Standard Deviation 0.2582 |
Primary
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)
Population: All treated participants with available pharmacokinetics data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baraclude | Trough Observed Plasma (Predose) Concentration (Ctrough) | 0 ng/mL | Standard Deviation 0 |