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

NCT02603497 | Completed Phase 1

• 1 other identifier: 015K-CL-PK11
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Patients With Impaired Renal Function

Keywords

ASP015K; impaired renal function; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetics (PK) parameter of ASP015K: AUCinf

  AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

  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 ASP015K: Cmax

  Cmax: Maximum concentration

  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

  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

  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 Adverse Events (AEs)

  Up to 7 days after the study drug dosing

• Safety assessed by Vital signs

  Supine blood pressure, supine pulse rate and axillary body temperature

  Up to 7 days after the study drug dosing

• Safety assessed by Laboratory tests

  Hematology, blood biochemistry and urinalysis

  Up to 7 days after the study drug dosing

• Safety assessed by 12-lead ECGs

  ECG: Electrocardiogram

  Up to 7 days after the study drug dosing

Secondary Outcomes (8)

• PK parameters of ASP015K: AUClast

  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

  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

  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

  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

  pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing

Study Arms (4)

Control (Subjects with normal renal function)

EXPERIMENTAL

Oral

Drug: ASP015K

Mild renal impairment

EXPERIMENTAL

Oral

Drug: ASP015K

Moderate renal impairment

EXPERIMENTAL

Oral

Drug: ASP015K

Severe renal impairment

EXPERIMENTAL

Oral

Drug: ASP015K

Interventions

ASP015K DRUG

oral

Control (Subjects with normal renal function); Mild renal impairment; Moderate renal impairment; Severe renal impairment

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Site JP00001

Tokyo, Japan

Location

Site JP00002

Tokyo, Japan

Location

Related Publications (2)

• 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.

  PMID: 33068028 DERIVED

• 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.

  PMID: 31729626 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

peficitinib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: November 24, 2015
• Primary Completion: December 19, 2016
• Study Completion: December 19, 2016
• Last Updated: October 16, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)