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

Phase 1

Completed

• Conditions: Hepatitis B Virus
• Interventions: Drug: Baraclude

• Registration Number: NCT03083821
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Study Start: 2017-05-16
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-19
• Results First Submitted: 2018-12-18
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Results First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Baraclude	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	Up to 24 hours	Cmax is defined as the peak plasma concentration
Trough Observed Plasma (Predose) Concentration (Ctrough)	prior to administration of drug (predose)	Ctrough is defined as the trough in observed plasma (predose) concentrations
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
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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Hachioji-shi, Tokyo, Japan