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

Primary Purpose

Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
acalabrutinib
Sponsored by
Acerta Pharma BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Impairment focused on measuring Hepatic, Acalabrutinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Women must be of non childbearing status
  • Understands the study procedures in the ICF and be willing and able to comply with the protocol.
  • Willingness and ability to swallow study drug capsule.
  • Adult men or women, 18 to 75 years of age

Hepatic-Impaired Subjects Only:

  • Subject has a diagnosis of chronic, stable HI.
  • Subject's score on the Child-Pugh scale must range from 10 to 15 at screening.

Exclusion Criteria

  • History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the PI.
  • Dosed in another clinical trial within 28 days before dosing of study drug and throughout the current study.
  • History or presence of drug abuse within 2 years before screening.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subjects with Severe Hepatic Impairment

Matched-Control Subjects

Arm Description

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.

Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib.

Outcomes

Primary Outcome Measures

Plasma Acalabrutinib PK Parameters
Area Under the Concentration-Time Curve
Maximum Plasma Acalabrutinib Concentration
Maximum Cmax

Secondary Outcome Measures

Full Information

First Posted
May 15, 2019
Last Updated
August 16, 2021
Sponsor
Acerta Pharma BV
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03968848
Brief Title
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
March 13, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerta Pharma BV
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
Keywords
Hepatic, Acalabrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with Severe Hepatic Impairment
Arm Type
Experimental
Arm Description
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.
Arm Title
Matched-Control Subjects
Arm Type
Experimental
Arm Description
Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib.
Intervention Type
Drug
Intervention Name(s)
acalabrutinib
Intervention Description
A 50-mg single oral dose of acalabrutinib will be administered.
Primary Outcome Measure Information:
Title
Plasma Acalabrutinib PK Parameters
Description
Area Under the Concentration-Time Curve
Time Frame
Severe HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 60, 72 hrs post-dose. Normal HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs post-dose.
Title
Maximum Plasma Acalabrutinib Concentration
Description
Maximum Cmax
Time Frame
Severe HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 60, 72 hrs post-dose. Normal HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs post-dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Women must be of non childbearing status Understands the study procedures in the ICF and be willing and able to comply with the protocol. Willingness and ability to swallow study drug capsule. Adult men or women, 18 to 75 years of age Hepatic-Impaired Subjects Only: Subject has a diagnosis of chronic, stable HI. Subject's score on the Child-Pugh scale must range from 10 to 15 at screening. Exclusion Criteria History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the PI. Dosed in another clinical trial within 28 days before dosing of study drug and throughout the current study. History or presence of drug abuse within 2 years before screening.
Facility Information:
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
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=
Description
Related Info
URL
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=
Description
Related Info

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

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