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NCT05303220 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
56
Enrollment target

NCT05303220 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 56 participants.

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The verdict

NCT05303220, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target

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.

Interventions

  • DRUG Placebo
  • DRUG Branebrutinib

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2022-04-08
Est. Completion 2022-08-18
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT05303220

The ClinicalTrials.gov registry entry for NCT05303220 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05303220 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05303220 about?

NCT05303220 is a clinical study titled "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". 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, eval...

What is the current status of trial NCT05303220?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2022-04-08. Estimated completion is 2022-08-18.

What interventions are being tested in trial NCT05303220?

The interventions under investigation include: Placebo (DRUG), Branebrutinib (DRUG).

Who is sponsoring clinical trial NCT05303220?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.