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A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

NCT06342700 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-09-03

No results posted yet for this study

Summary

This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.

The total study duration per participant is expected to be up to 36 days, including:

* Screening: up to 4 weeks
* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.
* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.
* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.

Conditions

Interventions

DRUG

Rilzabrutinib crystalline form

Pharmaceutical form:Film coated tablet Route of administration:Oral

DRUG

Rilzabrutinib amorphous form

Pharmaceutical form:Film coated tablet Route of administration:Oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2024-04-23
Completion
2024-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06342700 on ClinicalTrials.gov