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Pharmacokinetics Study in Patients With Impaired Hepatic Function | Clinical Trials | Clareo Health

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Pharmacokinetics Study in Patients With Impaired Hepatic Function

Pharmacokinetic Study of ASP015K - Evaluation of Pharmacokinetics in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function

NCT02586194•Astellas Pharma Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
+5 more criteria

Exclusion Criteria

•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
+36 more criteria

Locations (6)

Site JP00001

Fukuoka, Japan

Site JP00003

Kanagawa, Japan

Site JP00002

Tokyo, Japan

Site JP00004

Tokyo, Japan

Site JP00005

Tokyo, Japan

Site JP00006

Tokyo, Japan

Key Dates

Start Date

December 28, 2015

Primary Completion Date

September 27, 2016

Completion Date

September 27, 2016

Last Updated

October 16, 2024

Enrollment

ACTUAL participants

Conditions

Patients With Impaired Hepatic Function

Interventions

ASP015K

DRUG