Phase 1
Completed N=6
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
Source: ClinicalTrials.gov NCT03083821 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 8.17 ng/mL
Summary
A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
8.17 | — |
| PRIMARY Time of Maximum Observed Plasma Concentration (Tmax) |
0.667 | — |
| PRIMARY Trough Observed Plasma (Predose) Concentration (Ctrough) |
— | — |
| PRIMARY Observed Plasma Concentration at 24 Hours Postdose (C24) |
0.435 | — |
| PRIMARY Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] |
21.8 | — |
| PRIMARY Apparent Total Body Clearance (CLT/F) |
397 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03083821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.