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Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

NCT04768985 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-07-08

No results posted yet for this study

Summary

This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B) in the fasted state.

Conditions

  • Bioequivalence

Interventions

DRUG

Treatment A: Acalabrutinib tablet

Participants will receive fixed single doses of acalabrutinib tablet in 2 treatment periods, under fasted conditions.

DRUG

Treatment B: Acalabrutinib capsule

Participants will receive fixed single doses of acalabrutinib capsule in 2 treatment periods, under fasted conditions.

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, MD · Parexel Early Phase Clinical Unit Baltimore Harbor Hospital 3001 South Hanover St. Baltimore, MD 21225 USA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2021-05-10
Completion
2021-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04768985 on ClinicalTrials.gov