Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 50 for:    acalabrutinib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

Condition or disease Intervention/treatment Phase
Hepatic Impairment Hepatic Insufficiency Healthy Subjects Drug: acalabrutinib Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 12, 2018
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Plasma concentration of Acalabrutinib (ACP-196) to evaluate Area Under the Concentration-Time Curve (AUC) [ Time Frame: Study Days 1, 2, 3 and 4 ]
  2. Apparent total plasma clearance after oral administration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  3. Maximum observed concentration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  4. Time to reach Cmax [ Time Frame: Study Days 1, 2, 3 and 4 ]
  5. Time of the last measurable concentration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  6. Apparent terminal elimination rate constant [ Time Frame: Study Days 1, 2, 3 and 4 ]
  7. Apparent first-order terminal elimination half-life [ Time Frame: Study Days 1, 2, 3 and 4 ]
  8. Apparent volume of distribution during the terminal elimination phase after oral administration [ Time Frame: Study Days 1, 2, 3 and 4 ]
  9. Fraction of unbound drug in plasma [ Time Frame: Study Days 1, 2, 3 and 4 ]

Secondary Outcome Measures :
  1. Treatment-emergent adverse events [ Time Frame: Study Days 1, 2, 3, 4 and follow-up occurring 14 days after dosing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968848


Locations
Layout table for location information
United States, Florida
United States, Miami
Miami, Florida, United States, 33136
United States, Florida
Orlando, Florida, United States, 32809
United States, Tennessee
United States, Tennessee
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca

Layout table for additonal information
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT03968848     History of Changes
Other Study ID Numbers: ACE-HI-102
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acerta Pharma BV:
Hepatic
Acalabrutinib

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Hepatic Insufficiency
Liver Failure
Digestive System Diseases