MedTrace Logo

A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers

NCT04435483 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-07-22

No results posted yet for this study

Summary

This study is being conducted to support the clinical development of acalabrutinib in patients who are unable to swallow capsule and require nasogastric (NG) tube placement.

Conditions

  • Pharmacokinetics
  • Bioavailability

Interventions

DRUG

Acalabrutinib Treatment A

Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions. A single dose of 20 mg rabeprazole will be administered with 240 mL water, 2 hours prior to administration of acalabrutinib suspension. Treatment with rabeprazole 20 mg twice daily (with meals) will be started 3 days prior to the receiving the first dose of acalabrutinib suspension.

DRUG

Acalabrutinib Treatment B

Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions.

DRUG

Acalabrutinib Treatment C

Participants will receive a single dose of 100-mg acalabrutinib capsule, under fasted conditions. The acalabrutinib capsule will be administered with 240 mL of water.

Sponsors & Collaborators

  • Acerta Pharma, LLC

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • David Han, M.D. · PAREXEL Early Phase Clinical Unit-Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2020-06-26
Completion
2020-06-26
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 NCT04435483 on ClinicalTrials.gov