NCT03083821

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

Completed Phase 1 Results posted Last updated 18 November 2023

What this trial tests

Phase 1 trial testing Baraclude in Hepatitis B Virus in 6 participants. Completed in 19 December 2017.

Timeline

16 May 2017

Primary endpoint
19 December 2017

19 December 2017

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	16 May 2017
Primary completion	19 December 2017
Estimated completion	19 December 2017
Sites	1 location across Japan

Drugs / interventions tested

• Baraclude (ENTECAVIR) — full drug profile →

Conditions studied

• Hepatitis B Virus — all drugs for Hepatitis B Virus →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 20 to 70, any sex, with Hepatitis B Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Observed Plasma Concentration (Cmax) Primary · Up to 24 hours

Cmax is defined as the peak plasma concentration

Group	Value	95% CI
Baraclude	8.17	± 2.517

Time of Maximum Observed Plasma Concentration (Tmax) Primary · Up to 24 hours

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

Group	Value	95% CI
Baraclude	0.667	± 0.2582

Trough Observed Plasma (Predose) Concentration (Ctrough) Primary · prior to administration of drug (predose)

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

Group	Value	95% CI
Baraclude	0	± 0

Observed Plasma Concentration at 24 Hours Postdose (C24) Primary · 24 hours post-dose

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

Group	Value	95% CI
Baraclude	0.435	± 0.0678

Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] Primary · Up to 24 hours

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

Group	Value	95% CI
Baraclude	21.8	± 4.53

Apparent Total Body Clearance (CLT/F) Primary · Up to 24 hours

CLT/F is defined as the apparent total body clearance

Group	Value	95% CI
Baraclude	397	± 81.7

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.