Hepatic ImpairmentPhase 1NCT03968848
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
A Phase 1 study testing acalabrutinib in people with Hepatic Impairment and Hepatic Insufficiency, run by Acerta Pharma BV at 3 sites in United States.
Trial summary
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- What is being tested?
- acalabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2018to 29 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Knoxville, Tennessee, 37920
Research Site
Miami, Florida, 33136
Research Site
Orlando, Florida, 32809
About this study
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)
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
- Being tested
- acalabrutinib
- Keywords
- Hepatic, Acalabrutinib
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acalabrutinibDrug
A 50-mg single oral dose of acalabrutinib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: acalabrutinib |
| Matched-Control Subjects | Experimental | Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib. Receives: Drug: acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Acalabrutinib PK Parameters
Area Under the Concentration-Time Curve
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start12 Nov 2018
- Primary completion13 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Acerta Pharma BVThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968848
- Sponsor's protocol ID
- ACE-HI-102
- Status last verified
- Jul 2021
- First submitted
- 15 May 2019
- Last updated
- 10 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03968848
- Acronym / sponsor ID
- ACE-HI-102
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Keywords
- Hepatic, Acalabrutinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Posted 10 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Severe Hepatic Impairment | Experimental | Drug: acalabrutinibSubjects 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. |
| Matched-Control Subjects | Experimental | Drug: acalabrutinibSubjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Subject has a diagnosis of chronic, stable HI.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acalabrutinibA 50-mg single oral dose of acalabrutinib will be administered. | Drug | Matched-Control Subjects, Subjects with Severe Hepatic Impairment |
Primary outcome
Plasma Acalabrutinib PK Parameters
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.
Area Under the Concentration-Time Curve
Maximum Plasma Acalabrutinib Concentration
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.
Maximum Cmax
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing acalabrutinib in people with Hepatic Impairment and Hepatic Insufficiency, run by Acerta Pharma BV at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Acalabrutinib PK Parameters (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.