Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment

• Status: Completed
• Trial end date: 2019-09-27
• Target enrollment: 0
• Participant gender: All

Summary

To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with severe renal impairment and end stage renal disease not on dialysis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Dabrafenib

Criteria

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