Overview

To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Treatments:
Fluconazole
Hydroxyitraconazole
Itraconazole
Criteria
Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and
weigh at least 50 kg and no more than 100 kg. 2. Female subjects of non-childbearing
potential. 3. Have a calculated creatinine clearance (CrCL) >50 mL/min using the
Cockcroft-Gault formula.

Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one
parent or grandparent (maternal or paternal) is Japanese or non-Japanese. Asian (ie, China,
Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable.
3. Current or past history of central serous retinopathy or retinal vein
thrombosis,intra-ocular pressure >21 mmHg or uncontrolled glaucoma. 4. Any clinically
relevant abnormal findings in physical examination, hematology, clinical chemistry,
urinalysis, vital signs or ECG at baseline in the opinion of the investigator.