Trial Outcomes & Findings for A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting (NCT NCT03083821)

NCT ID: NCT03083821

Last Updated: 2023-11-18

Results Overview

Cmax is defined as the peak plasma concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: Up to 24 hours
• Results posted on: 2023-11-18

Participant Flow

Participant milestones

Measure	Baraclude Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All Treated Participants

Baseline characteristics by cohort

Measure	Baraclude n=6 Participants Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Age, Continuous	55.0 Years STANDARD_DEVIATION 9.96 • n=5 Participants • All Treated Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours

Population: All treated participants with available pharmacokinetics data

Cmax is defined as the peak plasma concentration

Outcome measures

Measure	Baraclude n=6 Participants Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Maximum Observed Plasma Concentration (Cmax)	8.17 ng/mL Standard Deviation 2.517

PRIMARY outcome

Timeframe: Up to 24 hours

Population: All treated participants with available pharmacokinetics data

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

Outcome measures

Measure	Baraclude n=6 Participants Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Time of Maximum Observed Plasma Concentration (Tmax)	0.667 Hours Standard Deviation 0.2582

PRIMARY outcome

Timeframe: prior to administration of drug (predose)

Population: All treated participants with available pharmacokinetics data

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

Outcome measures

Measure	Baraclude n=6 Participants Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Trough Observed Plasma (Predose) Concentration (Ctrough)	0 ng/mL Standard Deviation 0

PRIMARY outcome

Timeframe: 24 hours post-dose

Population: All treated participants with available pharmacokinetics data

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

Outcome measures

Measure	Baraclude n=6 Participants Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Observed Plasma Concentration at 24 Hours Postdose (C24)	0.435 ng/mL Standard Deviation 0.0678

PRIMARY outcome

Timeframe: Up to 24 hours

Population: All treated participants with available pharmacokinetics data

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

Outcome measures

Measure	Baraclude n=6 Participants Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]	21.8 h*ng/mL Standard Deviation 4.53

PRIMARY outcome

Timeframe: Up to 24 hours

Population: All treated participants with available pharmacokinetics data

CLT/F is defined as the apparent total body clearance

Outcome measures

Measure	Baraclude n=6 Participants Baraclude, 0.5 mg, 1 dose at 9:00 am of Day 1 (+/- 30 minutes), oral
Apparent Total Body Clearance (CLT/F)	397 mL/min Standard Deviation 81.7

Adverse Events

Baraclude

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submitter for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER