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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: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT05303220 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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
Bristol-Myers Squibb

1,025 total trials

What the finished NCT05303220 record still lists

NCT05303220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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

NCT05303220 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05303220's enrollment target sits among peer trials

56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05303220, the US trial registry maintained by the National Library of Medicine. NCT05303220 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.