Pharmacokinetics Study in Patients With Impaired Hepatic Function

NCT02586194 | Completed Phase 1

• 1 other identifier: 015K-CL-PK10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Patients With Impaired Hepatic Function

Keywords

Impaired hepatic function; Pharmacokinetics; ASP015K

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 72 hr 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 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

  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 (3)

Control (Subjects with normal hepatic function)

EXPERIMENTAL

Oral

Drug: ASP015K

Mild hepatic impairment

EXPERIMENTAL

Oral

Drug: ASP015K

Moderate hepatic impairment

EXPERIMENTAL

Oral

Drug: ASP015K

Interventions

ASP015K DRUG

Oral

Control (Subjects with normal hepatic function); Mild hepatic impairment; Moderate hepatic 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:

• 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.
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (6)

Site JP00001

Fukuoka, Japan

Location

Site JP00003

Kanagawa, Japan

Location

Site JP00002

Tokyo, Japan

Location

Site JP00004

Tokyo, Japan

Location

Site JP00005

Tokyo, Japan

Location

Site JP00006

Tokyo, Japan

Location

Related Publications (1)

• 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

MeSH Terms

Interventions

peficitinib

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: October 23, 2015
• First Posted: October 26, 2015
• Study Start: December 28, 2015
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: October 16, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (6)