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

NCT03968848 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ACE-HI-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hepatic Impairment; Hepatic Insufficiency; Healthy Subjects

Keywords

Hepatic; Acalabrutinib

Outcome Measures

Primary Outcomes (2)

• Plasma Acalabrutinib PK Parameters

  Area Under the Concentration-Time Curve

  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.

• Maximum Plasma Acalabrutinib Concentration

  Maximum Cmax

  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.

Study Arms (2)

Subjects with Severe Hepatic Impairment

EXPERIMENTAL

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

Matched-Control Subjects

EXPERIMENTAL

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

Drug: acalabrutinib

Interventions

acalabrutinib DRUG

A 50-mg single oral dose of acalabrutinib will be administered.

Matched-Control Subjects; Subjects with Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acerta Pharma BV: lead
• AstraZeneca: collaborator

Study Sites (3)

Research Site

Miami, Florida, 33136, United States

Location

Research Site

Orlando, Florida, 32809, United States

Location

Research Site

Knoxville, Tennessee, 37920, United States

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

acalabrutinib

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 30, 2019
• Study Start: November 12, 2018
• Primary Completion: March 13, 2019
• Study Completion: March 29, 2019
• Last Updated: September 10, 2021
• Results First Posted: September 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (3)