Status and phase
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About
This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.
Full description
This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Must understand and voluntarily sign a written informed consent form before participation.
Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.
Must have a body mass index between 18 and 33 kilograms/meter squared.
Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.
Must have a normal or clinically acceptable 12-lead electrocardiogram.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
14 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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