Patients With Impaired Hepatic FunctionPhase 1NCT02586194
Pharmacokinetics Study in Patients With Impaired Hepatic Function
A Phase 1 study testing ASP015K in people with Patients With Impaired Hepatic Function, run by Astellas Pharma Inc at 6 sites in Japan.
Trial summary
The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Impaired Hepatic Function
- What is being tested?
- ASP015K
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesJapan
- Study dates
- 28 Dec 2015to 27 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A subject is eligible for the study if all of the following apply:
- All subjects:
- Body weight: ≥40.0 kg and <90.0 kg
- Body mass index (BMI): ≥17.0 and <30.0 kg/m2
- Female subject must either:
- Be post-menopausal or surgically sterile.
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- Agree not to try to become pregnant starting at the time of informed consent throughout the study period and for 60 days after the final study drug administration if she is of childbearing potential.
- Agrees to use highly effective contraception
- Agrees not to donate sperm (for male)/ ova (for female) starting at the time of informed consent, and throughout the study period and for 90/60 days after the final study drug administration.
- Female subject agrees not to breastfeed starting at the time of informed consent, and throughout the study period and for 60 days after the final study drug administration.
- Agrees not to participate in a clinical trial, a post-marketing study, or a clinical study during the period from informed consent to post examination.
- A patient with impaired hepatic function:
- Impaired hepatic function Child-Pugh Score Class A (mild, 5-6 points) or Class B (moderate, 7-9 points).
- A subject with normal hepatic function:
- Healthy, as judged by the investigator/subinvestigator based on physical examinations and all tests obtained at screening and during the period from hospital admission to immediately before study drug administration.
Who cannot join
- A subject will be excluded from participation in this study if any of the following apply:
- All subjects:
- Received or is scheduled to receive any investigational drugs in other clinical trials, post-marketing studies or clinical research within 120 days before screening or during the period from screening to the hospital admission.
- Excessive alcohol or smoking habit.
- Applies to any of following concerns of tuberculosis:
- A history of active tuberculosis
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- Abnormalities detected on a chest X-ray test (at screening)
- Contact with infectious tuberculous patients
- Applies to any of following concerns except for tuberculosis:
- Concurrent or previous severe herpes zoster or herpes zoster disseminated
- More than 1 recurrence of localized herpes zoster
- Inpatient hospital care for severe infectious disease within 90 days before the hospital admission
- Treatment with intravenous antibiotics within 90 days before the hospital admission (prophylactic antibiotics are not applicable)
- Other than above, a people who has a risk of developing infectious diseases (e.g. urethral catheterisation) in judgment of the investigator/subinvestigator
- Vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission (inactivated vaccines such as influenza vaccine and pneumococcal vaccine are not applicable).
- Concurrent or previous drug allergies.
- A history of clinically serious allergies (serious allergies: Generalised urticaria which requires hospital admission, allergy which causes anaphylactic shock, etc.).
- Concurrent or previous cardiac failure NYHA class 3 or 4, long QT syndrome and congenital short QT syndrome.
- Development of (an) upper gastrointestinal symptom(s) within 7 days before the hospital admission.
- Concurrent or previous lymphatic disease.
- A history of digestive tract excision, except for a history of appendectomy.
- Previous use of ASP015K.
- A patient with impaired hepatic function:
- Unable to start washout of concomitant prohibited medications from at least 14 days prior to the study drug administration.
- Concurrent uncontrolled hypertension.
- Clinically significant abnormality detected on standard 12-lead electrocardiogram at screening or hospital admission.
- eGFR by the GFR estimating equation for Japanese <45 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
- Uncontrolled ascites or pleural effusion observed at screening.
- Concurrent hepatic encephalopathy Coma Scale II or more at screening.
- Underwent hepatic transplantation, or underwent hepatectomy within 1 year before screening.
- Concurrent or previous drug-induced hepatic disorder.
- Concurrent acute hepatic disease.
- With surgically-placed portosystemic shunts including transjugular intrahepatic portosystemic shunts.
- Concurrent biliary obstruction.
- A history of oesophageal haemorrhage or gastric varices haemorrhage within 180 days before screening.
- Irregular or acute, and clinically significant LFT values or changes in clinical symptoms from 30 days before screening to immediately before study drug administration.
- Platelet count <4 × 104/μL, or haemoglobin <9 g/dL at screening.
- Alcohol dependence or unable to remain abstinent during the specified period.
- Concurrent esophagus or gastric varices which have a high risk of clinically significant haemorrhage.
- Concurrent cerebrovascular disorder, serious heart disease, malignant tumour or a history within 5 years before screening, gastrointestinal disease, urinary disease, renal disease, endocrine disease, and respiratory disease.
- A subject with normal hepatic function:
- Received or is scheduled to receive medications (including over-the-counter drugs) within 7 days before the hospital admission.
- Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or the hospital admission.
- Meets any of the criteria for laboratory tests at screening or the hospital admission.
- eGFR by the GFR estimating equation for Japanese <60 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
- Concurrent or previous hepatic disease, cerebrovascular disorder, malignant tumor, heart disease, gastrointestinal disease, except for a history of appendicitis, renal disease, endocrine disease, respiratory disease, urological disease.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Site JP00001
Fukuoka
Site JP00003
Kanagawa
Site JP00002
Tokyo
Site JP00004
Tokyo
Site JP00005
Tokyo
Site JP00006
Tokyo
About this study
Official title: Pharmacokinetic Study of ASP015K - Evaluation of Pharmacokinetics in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function
The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.
- Conditions
- Patients With Impaired Hepatic Function
- Being tested
- ASP015K
- Keywords
- Impaired hepatic function, Pharmacokinetics, ASP015K
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP015KDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Control (Subjects with normal hepatic function) | Experimental | Oral Receives: Drug: ASP015K |
| Mild hepatic impairment | Experimental | Oral Receives: Drug: ASP015K |
| Moderate hepatic impairment | Experimental | Oral Receives: Drug: ASP015K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) parameter of ASP015K: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72 hr after dosing
PK parameter of ASP015K: Cmax
Cmax: Maximum concentration
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameter of metabolites: AUCinf
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameter of metabolites: Cmax
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
Safety assessed by AEs
Measured: Up to 7 days after the study drug dosing
Safety assessed by Vital signs
Supine blood pressure, supine pulse rate and axillary body temperature
Measured: Up to 7 days after the study drug dosing
Safety assessed by Laboratory tests
Hematology, blood biochemistry, and urinalysis
Measured: Up to 7 days after the study drug dosing
Safety assessed by 12-lead ECGs
Measured: Up to 7 days after the study drug dosing
Secondary outcomes (8)
PK parameters of ASP015K: AUClast
AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: t1/2
t1/2: Terminal elimination half-life
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: tmax
tmax: Time of Cmax
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: CL/F
CL/F: Apparent total systemic clearance
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: AUClast
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: t1/2
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: tmax
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start28 Dec 2015
- Primary completion27 Sep 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Impaired Hepatic FunctionStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586194
- Sponsor's protocol ID
- 015K-CL-PK10
- Status last verified
- Apr 2019
- First submitted
- 23 Oct 2015
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
PubMed 33068028
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of ASP015K - Evaluation of Pharmacokinetics in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT02586194
- Acronym / sponsor ID
- 015K-CL-PK10
- Conditions
- Patients With Impaired Hepatic Function
- Keywords
- Impaired hepatic function, Pharmacokinetics, ASP015K
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (Subjects with normal hepatic function) | Experimental | Drug: ASP015KOral |
| Mild hepatic impairment | Experimental | Drug: ASP015KOral |
| Moderate hepatic impairment | Experimental | Drug: ASP015KOral |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Body weight: ≥40.0 kg and <90.0 kg
- Body mass index (BMI): ≥17.0 and <30.0 kg/m2
- Female subject must either:
- Agrees to use highly effective contraception
- Agrees not to donate sperm (for male)/ ova (for female) starting at the time of informed consent, and throughout the study period and for 90/60 days after the final study drug administration.
Key exclusion criteria (46 listed)
- A subject will be excluded from participation in this study if any of the following apply:
- Received or is scheduled to receive any investigational drugs in other clinical trials, post-marketing studies or clinical research within 120 days before screening or during the period from screening to the hospital admission.
- Excessive alcohol or smoking habit.
- Applies to any of following concerns of tuberculosis:
- Applies to any of following concerns except for tuberculosis:
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 |
|---|---|---|
| ASP015KOral | Drug | Control (Subjects with normal hepatic function), Mild hepatic impairment, Moderate hepatic impairment |
Primary outcome
Pharmacokinetics (PK) parameter of ASP015K: AUCinf
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72 hr after dosing
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameter of ASP015K: Cmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
Cmax: Maximum concentration
PK parameter of metabolites: AUCinf
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameter of metabolites: Cmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
Safety assessed by AEs
Time frame: Up to 7 days after the study drug dosing
Safety assessed by Vital signs
Time frame: Up to 7 days after the study drug dosing
Supine blood pressure, supine pulse rate and axillary body temperature
Safety assessed by Laboratory tests
Time frame: Up to 7 days after the study drug dosing
Hematology, blood biochemistry, and urinalysis
Safety assessed by 12-lead ECGs
Time frame: Up to 7 days after the study drug dosing
8 secondary outcomes
PK parameters of ASP015K: AUClast
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: t1/2
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: tmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: CL/F
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: Vz/F
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: AUClast
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: t1/2
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: tmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 33068028Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
6 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 ASP015K in people with Patients With Impaired Hepatic Function, run by Astellas Pharma Inc at 6 sites in Japan.
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 15 inclusion and 46 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics (PK) parameter of ASP015K: AUCinf (time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72 hr after dosing). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586194, which also lists 1 linked publication.
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 16 Oct 2024.