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

NCT03083821 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AI463-528
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis B Virus

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax)

  Cmax is defined as the peak plasma concentration

  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

  Up to 24 hours

• Trough Observed Plasma (Predose) Concentration (Ctrough)

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

  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

  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

  Up to 24 hours

• Apparent Total Body Clearance (CLT/F)

  CLT/F is defined as the apparent total body clearance

  Up to 24 hours

Study Arms (1)

Arm A

EXPERIMENTAL

Drug: Baraclude

Interventions

Baraclude DRUG

Specified dose on specified day

Arm A

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Hachioji-shi, Tokyo, 1920071, Japan

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavir

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: May 16, 2017
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)