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

Primary Purpose

Hepatitis B Virus

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Baraclude
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B Virus

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)
Time of maximum observed plasma concentration (Tmax)
Trough observed plasma (predose) concentration (Ctrough)
Observed plasma concentration at 24 hours postdose (C24)
Area under the concentration-time curve in one dosing interval [AUC(TAU)]
Apparent total body clearance (CLT/F)

Secondary Outcome Measures

Full Information

First Posted
March 14, 2017
Last Updated
March 8, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03083821
Brief Title
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
Official Title
A Clinical Study to Evaluate the Steady State Pharmacokinetics of Baraclude in Participants With Hepatitis B Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
December 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Baraclude
Intervention Description
Specified dose on specified day
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 24 hours
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to 24 hours
Title
Trough observed plasma (predose) concentration (Ctrough)
Time Frame
Up to 24 hours
Title
Observed plasma concentration at 24 hours postdose (C24)
Time Frame
Up to 24 hours
Title
Area under the concentration-time curve in one dosing interval [AUC(TAU)]
Time Frame
Up to 24 hours
Title
Apparent total body clearance (CLT/F)
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
1920071
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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