- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02586194
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
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
-
Fukuoka, Japan
- Site JP00001
-
Kanagawa, Japan
- Site JP00003
-
Tokyo, Japan
- Site JP00006
-
Tokyo, Japan
- Site JP00004
-
Tokyo, Japan
- Site JP00005
-
Tokyo, Japan
- Site JP00002
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
- 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.
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
- 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).
- 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:
- Unable to start washout of concomitant prohibited medications from at least 14 days prior to the study drug administration.
- Concurrent uncontrolled hypertension.
- Clinically significant abnormality detected on standard 12-lead electrocardiogram at screening or hospital admission.
- eGFR by the GFR estimating equation for Japanese <45 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
- Uncontrolled ascites or pleural effusion observed at screening.
- Concurrent hepatic encephalopathy Coma Scale II or more at screening.
- Underwent hepatic transplantation, or underwent hepatectomy within 1 year before screening.
- Concurrent or previous drug-induced hepatic disorder.
- Concurrent acute hepatic disease.
- With surgically-placed portosystemic shunts including transjugular intrahepatic portosystemic shunts.
- Concurrent biliary obstruction.
- A history of oesophageal haemorrhage or gastric varices haemorrhage within 180 days before screening.
- Irregular or acute, and clinically significant LFT values or changes in clinical symptoms from 30 days before screening to immediately before study drug administration.
- Platelet count <4 × 104/μL, or haemoglobin <9 g/dL at screening.
- Alcohol dependence or unable to remain abstinent during the specified period.
- Concurrent esophagus or gastric varices which have a high risk of clinically significant haemorrhage.
- Concurrent cerebrovascular disorder, serious heart disease, malignant tumour or a history within 5 years before screening, gastrointestinal disease, urinary disease, renal disease, endocrine disease, and respiratory disease.
A subject with normal hepatic function:
- Received or is scheduled to receive medications (including over-the-counter drugs) within 7 days before the hospital admission.
- Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or the hospital admission.
- Meets any of the criteria for laboratory tests at screening or the hospital admission.
- eGFR by the GFR estimating equation for Japanese <60 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
- Concurrent or previous hepatic disease, cerebrovascular disorder, malignant tumor, heart disease, gastrointestinal disease, except for a history of appendicitis, renal disease, endocrine disease, respiratory disease, urological disease.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Control (Subjects with normal hepatic function)
Oral
|
Oral
|
Experimenteel: Mild hepatic impairment
Oral
|
Oral
|
Experimenteel: Moderate hepatic impairment
Oral
|
Oral
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Veiligheid beoordeeld door vitale functies
Tijdsspanne: Tot 7 dagen na toediening van het onderzoeksgeneesmiddel
|
Liggende bloeddruk, liggende hartslag en oksellichaamstemperatuur
|
Tot 7 dagen na toediening van het onderzoeksgeneesmiddel
|
Veiligheid beoordeeld door laboratoriumtests
Tijdsspanne: Tot 7 dagen na toediening van het onderzoeksgeneesmiddel
|
Hematologie, bloedbiochemie en urineonderzoek
|
Tot 7 dagen na toediening van het onderzoeksgeneesmiddel
|
Pharmacokinetics (PK) parameter of ASP015K: AUCinf
Tijdsspanne: 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
|
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
Tijdsspanne: 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
|
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
Tijdsspanne: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
|
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
Tijdsspanne: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
|
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
Tijdsspanne: Up to 7 days after the study drug dosing
|
Up to 7 days after the study drug dosing
|
|
Safety assessed by 12-lead ECGs
Tijdsspanne: Up to 7 days after the study drug dosing
|
Up to 7 days after the study drug dosing
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
PK parameters of ASP015K: AUClast
Tijdsspanne: 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
|
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
Tijdsspanne: 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
|
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
Tijdsspanne: 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
|
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
Tijdsspanne: 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
|
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
Tijdsspanne: 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
|
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 metabolites: AUClast
Tijdsspanne: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
|
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 metabolites: t1/2
Tijdsspanne: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
|
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 metabolites: tmax
Tijdsspanne: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
|
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 015K-CL-PK10
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op ASP015K
-
Astellas Pharma Global Development, Inc.VoltooidGezonde vrijwilligers | Farmacokinetiek van ASP015K | VoedseleffectVerenigde Staten
-
Astellas Pharma IncVoltooidPatiënten met een verminderde nierfunctieJapan
-
Astellas Pharma IncVoltooidGezonde onderwerpen | Farmacokinetiek van ASP015KVerenigde Staten
-
Astellas Pharma IncVoltooidGezonde onderwerpen | Farmacodynamiek | Farmacokinetiek van ASP015KVerenigde Staten
-
Astellas Pharma IncVoltooidGezonde onderwerpen | Biologische beschikbaarheid van ASP015K | Farmacokinetiek van ASP015KVerenigde Staten
-
Astellas Pharma IncVoltooidGezonde onderwerpen | Farmacokinetiek van ASP015KVerenigde Staten
-
Astellas Pharma China, Inc.VoltooidGezonde vrijwilligersChina
-
Astellas Pharma IncVoltooidArtritis, reumatoïdeJapan, Korea, republiek van, Taiwan
-
Astellas Pharma Global Development, Inc.VoltooidArtritis, reumatoïdeVerenigde Staten, Polen, Tsjechië, Bulgarije, Hongarije, Mexico
-
Astellas Pharma IncVoltooidGezonde onderwerpen | Biologische beschikbaarheid van ASP015K | Farmacokinetiek van ASP015KVerenigde Staten