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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.
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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:
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:
A subject with normal hepatic function:
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:
Applies to any of following concerns except for tuberculosis:
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).
Concurrent or previous drug allergies.
A history of clinically serious allergies (serious allergies: Generalised urticaria which requires hospital admission, allergy which causes anaphylactic shock, etc.).
Concurrent or previous cardiac failure NYHA class 3 or 4, long QT syndrome and congenital short QT syndrome.
Development of (an) upper gastrointestinal symptom(s) within 7 days before the hospital admission.
Concurrent or previous lymphatic disease.
A history of digestive tract excision, except for a history of appendectomy.
Previous use of ASP015K.
A patient with impaired hepatic function:
A subject with normal hepatic function:
Primary purpose
Allocation
Interventional model
Masking
24 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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