Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and its Metabolite

Study identifier:ACE-HI-102

ClinicalTrials.gov identifier:NCT03968848

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Open-Label, Single-Dose Study to Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and its Metabolite (ACP-5862)

Medical condition

Hepatic Impairment, Hepatic insufficiency, Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

acalabrutinib

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 12 Nov 2018

Primary Completion Date: 13 Mar 2019

Study Completion Date: 29 Mar 2019

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2021 by Acerta Pharma BV

Collaborators

AstraZeneca

Inclusion and exclusion criteria

Location

Research Site

Miami, Florida, United States, 33136

Location

Research Site

Orlando, Florida, United States, 32809

Location

Research Site

Knoxville, Tennessee, United States, 37920

Arms	Assigned Interventions
Experimental: Subjects with Severe Hepatic Impairment Subjects with severe hepatic impairment (score of 10 to 15 on the Child-Pugh scale) will be administrated a 50-mg single oral dose of acalabrutinib.	Drug: acalabrutinib A 50-mg single oral dose of acalabrutinib will be administered.
Experimental: Matched-Control Subjects Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib.	Drug: acalabrutinib A 50-mg single oral dose of acalabrutinib will be administered.

Documents available

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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and its Metabolite

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Documents available

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-HI-102&attachmentIdentifier=8655882d-974a-4d05-b3ae-39c27691e65e&fileName=ACE-HI-102_Final_SAP_25Apr2019_REDACTED.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-HI-102&attachmentIdentifier=2213f411-0d84-4ee1-8ae4-4b7c9c46a5d4&fileName=ACE-HI-102_Final_Protocol_04Jun2018_RED_Redacted.pdf&versionIdentifier=

Trial Results Summaries

Contacts

Contact

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-HI-102&amp;attachmentIdentifier=8655882d-974a-4d05-b3ae-39c27691e65e&amp;fileName=ACE-HI-102_Final_SAP_25Apr2019_REDACTED.pdf&amp;versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-HI-102&amp;attachmentIdentifier=2213f411-0d84-4ee1-8ae4-4b7c9c46a5d4&amp;fileName=ACE-HI-102_Final_Protocol_04Jun2018_RED_Redacted.pdf&amp;versionIdentifier=

Trial Results Summaries

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-HI-102&attachmentIdentifier=8655882d-974a-4d05-b3ae-39c27691e65e&fileName=ACE-HI-102_Final_SAP_25Apr2019_REDACTED.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-HI-102&attachmentIdentifier=2213f411-0d84-4ee1-8ae4-4b7c9c46a5d4&fileName=ACE-HI-102_Final_Protocol_04Jun2018_RED_Redacted.pdf&versionIdentifier=