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Patients With Impaired Renal FunctionPhase 1NCT02603497

Pharmacokinetics Study in Patients With Impaired Renal Function and Subjects With Normal Renal Function

A Phase 1 study testing ASP015K in people with Patients With Impaired Renal Function, run by Astellas Pharma Inc at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to compare the pharmacokinetics of ASP015K in patients with impaired renal function and subjects with normal renal 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 Renal 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
31 participants
Where
2 sitesJapan
Study dates
24 Nov 2015to 19 Dec 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

  • All subject
  • Body weight): ≥40.0 kg and <90.0 kg
  • Body mass index BMI: ≥17.6 and <30.0
  • Female subject must either:
  • Be post-menopausal or surgically sterile.
  • 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.
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  • Female subjects who agree not to breastfeed starting at informed consent and throughout the study period and for 60 days after the final study drug administration
  • Agree not to donate ova for female / sperm for male starting at informed consent and throughout the study period and for 60/90 days after the final study drug administration
  • Agree to use highly effective contraception
  • Patients with impaired renal function
  • Patients with eGFR by GFR predictive equation for Japanese within the following ranges at screening and who is not undergoing dialysis.
  • Patients with mild impaired renal function (eGFR; ≥60 mL/min/1.73 m2 and <90 mL/min/1.73 m2)
  • Patients with moderate impaired renal function (eGFR; ≥30 mL/min/1.73 m2 and <60 mL/min/1.73 m2)
  • Patients with severe impaired renal function (eGFR; ≥15 mL/min/1.73 m2 and <30 mL/min/1.73 m2)
  • Patients whose treatment regimen (including diet) for renal impairment or complications remain unchanged within 14 days prior to hospital admission day (Day -1), or patients who receive treatments (including diet) that need not to be changed during the period from 14 days before hospital admission day (Day -1) to follow-up examination in the opinion of the investigator or sub-investigator.
  • Subjects with normal renal function
  • Subjects with eGFR by GFR predictive equation for Japanese ≥ 90 mL/min/1.73 m2 at screening
  • Subjects who is healthy, as judged by the investigator or sub-investigator based on physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission to immediately before study drug administration

Who cannot join

  • All subjects
  • Received or is scheduled to receive any study drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day (Day -1)
  • Deviate from the following provided range of blood pressure, pulse rate, body temperature and standard 12-lead ECG at screening or the hospital admission day (Day -1)
  • Subjects who meet any of the criteria for laboratory tests at screening or the hospital admission day (Day -1). Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
  • Complication or history of drug allergies
  • Developed upper gastrointestinal symptoms within 7 days before the hospital admission day (Day -1)
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  • Complication or history of hepatic disease
  • Complication of long QT syndrome, congenital short QT syndrome
  • A history of gastrointestinal resection
  • Subjects with a complication or history of endocrine disease
  • Subjects with a complication or history of malignant tumor
  • Subjects with a complication or history of lymphatic disease
  • Applies to any of following concerns of tuberculosis
  • A history of active tuberculosis
  • Abnormalities detected on a chest X-ray test (at screening)
  • Contact with infectious tuberculous patients
  • Applies to any of following concerns, with regard to infection except for tuberculosis
  • A complication or history of severe herpes zoster or herpes zoster disseminated
  • At least twice of relapse of localized herpes zoster
  • Inpatient hospital care for severe infectious diseases within 90 days before the hospital admission day (Day -1)
  • Treatment with intravenous antibiotics within 90 days before the hospital admission day (Day -1) (prophylactic antibiotics are not applicable).
  • Other than above, a subject with a high risk of developing infectious disease (e.g. subjects with urethral catheterisation) in judgment of the investigator or sub-investigator.
  • Vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission day (Day -1) (Inactivated vaccines such as influenza vaccine and pneumococcal vaccine are not applicable.)
  • A history of clinically serious allergies
  • Previously received administration of ASP015K
  • Excessive alcohol drinking or smoking
  • Patients with impaired renal function
  • Patients who received or are scheduled to receive any new drugs within 14 days before the hospital admission day (Day -1)
  • Patients who receive dialysis, or received renal transplantation
  • Patients who developed acute changes in renal function and in all laboratory test results within 28 days before screening and patients with impaired renal function who may need new concomitant therapies during the study period.
  • Patients with a complication of severe heart disease, NYHA class III or IV cardiac failure.
  • Complication of alimentary disease, cerebrovascular disorder, respiratory disease
  • Patients with tubular dysfunction, obvious urination impaired
  • Subjects with normal renal function
  • Subjects who received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within seven days before the hospital admission day (Day -1).
  • Subjects with a complication or history of heart disease, respiratory disease, alimentary disease, renal disease, endocrine disease, urological disease, cerebrovascular disorder

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Site JP00001

    Tokyo

  • Site JP00002

    Tokyo

Other trials in Japan

About this study

Official title: Pharmacokinetic (PK) Study of ASP015K -Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Subjects With Normal Renal Function-

The objective of this study is to compare the pharmacokinetics of ASP015K in patients with impaired renal function and subjects with normal renal function.

Being tested
ASP015K
Keywords
ASP015K, impaired renal function, Pharmacokinetics
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP015KDrug

    oral

Study groups in NCT02603497
Study groupRoleWhat they receive
Control (Subjects with normal renal function)ExperimentalOral
Receives: Drug: ASP015K
Mild renal impairmentExperimentalOral
Receives: Drug: ASP015K
Moderate renal impairmentExperimentalOral
Receives: Drug: ASP015K
Severe renal impairmentExperimentalOral
Receives: Drug: ASP015K

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 72hr after dosing

  2. 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

  3. 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

  4. 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

  5. Safety assessed by Adverse Events (AEs)

    Measured: Up to 7 days after the study drug dosing

  6. 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

  7. Safety assessed by Laboratory tests

    Hematology, blood biochemistry and urinalysis

    Measured: Up to 7 days after the study drug dosing

  8. Safety assessed by 12-lead ECGs

    ECG: Electrocardiogram

    Measured: Up to 7 days after the study drug dosing

Secondary outcomes (8)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted11 Nov 2015 (estimated)
  2. Study start24 Nov 2015
  3. Primary completion19 Dec 2016
  4. Study completion19 Dec 2016

Resources

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603497
Sponsor's protocol ID
015K-CL-PK11
Status last verified
Apr 2019
First submitted
10 Nov 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

  • Miyatake D, Shibata T, Shibata M, Kaneko Y, Oda K, Nishimura T, Katashima M, Sekino H, Furihata K, Urae A. Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function. Clin Drug Investig. 2020 Feb;40(2):149-159. doi: 10.1007/s40261-019-00873-7.

    PubMed 31729626

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP015K in people with Patients With Impaired Renal Function, run by Astellas Pharma Inc at 2 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 18 inclusion and 36 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 2 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 72hr 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 NCT02603497, which also lists 2 linked publications.

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.

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