Status and phase
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About
To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.
Enrollment
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Inclusion and exclusion criteria
Inclusion criteria (for all subjects)
Additional inclusion criteria for patients with normal hepatic function (Control group):
Additional inclusion criteria for hepatic impaired subjects:
Exclusion criteria for all subjects
Additional exclusion criteria for healthy subjects (control group):
Additional exclusion criteria for subjects with hepatic impairment:
Other protocol-defined inclusion/exclusion may apply.
Primary purpose
Allocation
Interventional model
Masking
5 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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