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Bruton's Tyrosine Kinase (BTK) Inhibitor

Part 3 Treatment A for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post last scheduled visit
Awards & highlights

Study Summary

The purpose of this study is to assess the relative bioavailability of branebrutinib tablet formulation relative to the capsule formulation in order to identify doses that would provide exposures similar to the capsule formulation over the dose range that may be used in future clinical studies, evaluate the effect of food on the bioavailability of branebrutinib from a tablet formulation at a dose projected to provide similar pharmacokinetics (PK) as the 9 mg capsule formulation, and evaluate the safety and the PK of multiple oral dose of tablet formulation of branebrutinib in healthy participants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post last scheduled visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post last scheduled visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from time zero extrapolated to infinite time (AUC(INF))
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
Maximum observed plasma concentration (Cmax)
+1 more
Secondary outcome measures
Apparent total body clearance (CLT/F)
Apparent volume of distribution (Vz/F)
Geometric mean ratio of AUC(0-T)
+8 more

Side effects data

From 2022 Phase 2 trial • 17 Patients • NCT05014438
33%
Eczema herpeticum
33%
Visual impairment
33%
Pyrexia
33%
Depressed mood
33%
Lymphadenopathy
33%
Furuncle
33%
Nodule
33%
Skin mass
33%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment 1
Treatment 4
Treatment 2
Placebo
Treatment 3

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3 Treatment AExperimental Treatment1 Intervention
Group II: Part 2 Treatment CExperimental Treatment1 Intervention
Group III: Part 2 Treatment BExperimental Treatment1 Intervention
Group IV: Part 2 Treatment AExperimental Treatment1 Intervention
Group V: Part 1 Treatment DExperimental Treatment1 Intervention
Group VI: Part 1 Treatment CExperimental Treatment1 Intervention
Group VII: Part 1 Treatment BExperimental Treatment1 Intervention
Group VIII: Part 1 Treatment AExperimental Treatment1 Intervention
Group IX: Part 3 Treatment BPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Branebrutinib
2022
Completed Phase 2
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,976 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants
2022. "A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05303220.
~19 spots leftby Apr 2025
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