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OpenTrials
Completed

NCT Number: NCT03083821

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

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

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Key information

Conditions

Hepatitis B Virus Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Hachioji-shi, Tokyo, 1920071, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baraclude

Drug

Specified dose on specified day

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 24 hours

    Cmax is defined as the peak plasma concentration

  2. Time of Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to 24 hours

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

  3. Trough Observed Plasma (Predose) Concentration (Ctrough)

    Time frame: prior to administration of drug (predose)

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

  4. Observed Plasma Concentration at 24 Hours Postdose (C24)

    Time frame: 24 hours post-dose

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

  5. Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]

    Time frame: Up to 24 hours

    AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval

  6. Apparent Total Body Clearance (CLT/F)

    Time frame: Up to 24 hours

    CLT/F is defined as the apparent total body clearance

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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