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

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ClinicalTrials.gov Identifier: NCT03968848
Recruitment Status : Completed
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE November 12, 2018
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Plasma concentration of Acalabrutinib (ACP-196) to evaluate Area Under the Concentration-Time Curve (AUC) [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Apparent total plasma clearance after oral administration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Maximum observed concentration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Time to reach Cmax [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Time of the last measurable concentration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Apparent terminal elimination rate constant [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Apparent first-order terminal elimination half-life [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Apparent volume of distribution during the terminal elimination phase after oral administration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  • Fraction of unbound drug in plasma [ Time Frame: Study Days 1, 2, 3 and 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
Treatment-emergent adverse events [ Time Frame: Study Days 1, 2, 3, 4 and follow-up occurring 14 days after dosing ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
Official Title  ICMJE 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)
Brief Summary This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatic Impairment
  • Hepatic Insufficiency
  • Healthy Subjects
Intervention  ICMJE Drug: acalabrutinib
A 50-mg single oral dose of acalabrutinib will be administered.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: acalabrutinib
  • Experimental: Matched-Control Subjects
    Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib.
    Intervention: Drug: acalabrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 29, 2019
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968848
Other Study ID Numbers  ICMJE ACE-HI-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE Not Provided
PRS Account Acerta Pharma BV
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP