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

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: NCT02603497
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Patients With Impaired Renal Function Drug: ASP015K Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic (PK) Study of ASP015K -Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Subjects With Normal Renal Function-
Actual Study Start Date : November 24, 2015
Actual Primary Completion Date : December 19, 2016
Actual Study Completion Date : December 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Control (Subjects with normal renal function)
Oral
Drug: ASP015K
oral

Experimental: Mild renal impairment
Oral
Drug: ASP015K
oral

Experimental: Moderate renal impairment
Oral
Drug: ASP015K
oral

Experimental: Severe renal impairment
Oral
Drug: ASP015K
oral




Primary Outcome Measures :
  1. 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 ]
    AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

  2. 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

  3. 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 ]
  4. 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 ]
  5. Safety assessed by Adverse Events (AEs) [ Time Frame: Up to 7 days after the study drug dosing ]
  6. 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

  7. Safety assessed by Laboratory tests [ Time Frame: Up to 7 days after the study drug dosing ]
    Hematology, blood biochemistry and urinalysis

  8. Safety assessed by 12-lead ECGs [ Time Frame: Up to 7 days after the study drug dosing ]
    ECG: Electrocardiogram


Secondary Outcome Measures :
  1. 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 ]
    AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration

  2. 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 ]
    t1/2: Terminal elimination half-life

  3. 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 ]
    tmax: Time of Cmax

  4. 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 ]
    CL/F: Apparent total systemic clearance

  5. 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 ]
    Vz/F: Apparent volume of distribution during the terminal elimination phase

  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.
  • 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

Exclusion Criteria:

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)
  • 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

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): NCT02603497


Locations
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Japan
Site JP00001
Tokyo, Japan
Site JP00002
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02603497    
Other Study ID Numbers: 015K-CL-PK11
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc:
ASP015K
impaired renal function
Pharmacokinetics
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Peficitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs