Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment

Inclusion Criteria:

All subjects:

- Females must be of non-childbearing potential or must have negative pregnancy results
at screening

- Good health as determined by lack of clinically significant findings

- Subjects must have a BMI between 18.0 kg/m2 and 38.0 kg/m2, with a body weight of at
least 50 kg and no more than 140 kg

- Vitals signs within normal range

- Laboratory values at screening within local normal ranges or considered non-clinically
significant Additional criteria for renal impairment subjects

- Stable renal disease without evidence of renal progression in the past 28 days prior
to dosing

- Additional criteria for healthy matched subjects:

- Matched to at least 1 renal impairment subject by race, age (+/-10 years), gender and
weight (+/-10%)

- An absolute GFR of at least 90 ml/min

Exclusion Criteria for all subjects:

- Significant acute illness within the two weeks prior to dosing

- History or current diagnosis of cardiac disease indicating significant risk such as
uncontrolled or significant cardiac disease or clinically significant ECG
abnormalities

- Subjects will be screened for drugs of abuse

- History of drug or alcohol abuse within 6 months prior to dosing or evidence of such
abuse as indicated by laboratory values at screening or baseline.

- Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism or excretion of drugs.

- History of malignancy of any organ system, treated or untreated, within 5 years,
regardless of where there is recurrence or metastases.

- Use of drugs known to prolong the QT interval within 4 weeks prior to dosing and for
the duration of the study.

- Use of drugs know to affect CYP3A4 and/or CYP2C8 including both (strong or moderate)
inhibitors and inducers, within 7 days prior to dosing or during the current study are
prohibited

Other protocol-defined inclusion/exclusion may apply.