Clinical trial · Interventional
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
NCT02063230CI-TRIAL-00023191completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selumetinib 25mg | Drug | Selumetinib | ALIAS |
| Selumetinib 50mg | Drug | Selumetinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Selumetinib HV
- description
- Healthy volunteers (HV)
- interventionNames
- Drug: Selumetinib 50mg
- type
- EXPERIMENTAL
- label
- Selumetinib mild impairment
- description
- Mild (Child Pugh A) hepatic impaired patients
- interventionNames
- Drug: Selumetinib 50mg
- type
- EXPERIMENTAL
- label
- Selumetinib moderate impairment
- description
- Moderate (Child Pugh B) hepatic impaired patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria for all participants: 1. 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: 2. 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: 3. 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: 1. Subjects of Japanese or non-Japanese Asian ethnicity 2. 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. 3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the investigational product 4. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day. Exclusion criteria for hepatic impaired patients only 5. Undergone liver transplantation. -
References
Publications (0)
Data not yet available
No reference posted for this study.