- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02063230
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) Following Single Oral Dosing to Healthy Subjects and to Subjects With Mild, Moderate, and Severe Hepatic Impairment
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Orlando, Florida, Forenede Stater
- Research Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria for all participants:
Subjects will be males or females (non-childbearing potential) aged 18 years or more and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive.
Inclusion Critera only for hepatic impaired patients:
Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study.
Inclusion Criteria only for healthy volunteers:
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed before the administration of the investigational product.
Exclusion Criteria for all participants:
- Subjects of Japanese or non-Japanese Asian ethnicity
- Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the investigational product
Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day.
Exclusion criteria for hepatic impaired patients only
- Undergone liver transplantation. -
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Selumetinib HV
Healthy volunteers (HV)
|
HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1
|
|
Eksperimentel: Selumetinib mild impairment
Mild (Child Pugh A) hepatic impaired patients
|
HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1
|
|
Eksperimentel: Selumetinib moderate impairment
Moderate (Child Pugh B) hepatic impaired patients
|
HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1
|
|
Eksperimentel: Selumetinib severe impairment
Severe (Child Pugh C) hepatic impairment patients
|
Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
AUC (0 to Infinity) of Total Selumetinib
Tidsramme: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
|
Cmax of Total Selumetinib
Tidsramme: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
|
Dose Normalized AUC, Total Selumetinib
Tidsramme: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
|
Dose Normalized Cmax, Total Selumetinib
Tidsramme: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
|
Dose Normalized AUC, Unbound Selumetinib
Tidsramme: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
|
Dose Normalized Cmax, Unbound Selumetinib
Tidsramme: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Thomas C Marbury, MD, Orlando Clinical Research Center, 5055 S Orange Avenue, Orlando, Florida, United States.
- Studieleder: Ian Smith, MD, Astrazeneca, UK
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D1532C00082
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