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A Study to Evaluate Relative Bioavailability, Proton Pump Inhibitor (PPI) (Rabeprazole) Effect, Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects

NCT04488016 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-02-03

No results posted yet for this study

Summary

This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects (males or females). The study will be divided in 2 study parts; following a review of the safety and Pharmacokinetics (PK) data from Part 1, the study is planned to be continued with Part 2.

Conditions

  • Bioavailability
  • B-cell Lymphoid Cancer

Interventions

DRUG

Treatment A- Part 1

Subjects will receive 100 mg acalabrutinib capsule, fasted state;

DRUG

Treatment B- Part 1

Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state

DRUG

Treatment C - Part 1

Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fed state

DRUG

Treatment D- Part 1

Subjects will receive Rabeprazole 20 mg QD (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1) and following prior administration of rabeprazole 20 mg Twice per day (BID) (with meals) on Days -3, -2 and -1.

DRUG

Treatment A-Part 2

Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state

DRUG

Treatment B - Part 2

Subjects will receive 100 mg acalabrutinib tablet (Variant 2), fasted state

DRUG

Treatment C - Part 2

Subjects will receive 100 mg acalabrutinib tablet (Variant 3), fasted state

DRUG

Treatment D - Part 2

Subjects will receive 100 mg acalabrutinib solution, (Variant 4), fasted state

Sponsors & Collaborators

  • Acerta Pharma, LLC

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Ronald Goldwater,, MD · PAREXEL Early Phase Clinical Unit Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2021-01-20
Completion
2021-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04488016 on ClinicalTrials.gov