Phase 1
Completed N=32
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
Source: ClinicalTrials.gov NCT02063230 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: AUC (0 to Infinity) of Total Selumetinib — 2300; 4300; 1680; 2680 ng*h/mL
Summary
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC (0 to Infinity) of Total Selumetinib |
2300; 4300; 1680; 2680 | — |
| PRIMARY Cmax of Total Selumetinib |
741; 1210; 370; 944 | — |
| PRIMARY Dose Normalized AUC, Total Selumetinib |
45.9; 85.1; 84.3; 53.6 | — |
| PRIMARY Dose Normalized Cmax, Total Selumetinib |
14.8; 23.6; 18.5; 18.9 | — |
| PRIMARY Dose Normalized AUC, Unbound Selumetinib |
0.127; 0.259; 0.583; 0.184 | — |
| PRIMARY Dose Normalized Cmax, Unbound Selumetinib |
0.0409; 0.0716; 0.128; 0.0647 | — |
Eligibility Criteria
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. -
Data sourced from ClinicalTrials.gov (NCT02063230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.