Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment
Completed · Phase 1
Conditions studied: Renal Impairment
In brief
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.
Key facts
- Study ID
- NCT02852239
- Run by
- Novartis Pharmaceuticals
- People needed
- 22
- Starts
- 2016-12-19
- Expected to finish
- 2019-09-27
- Last updated by the study team
- 2020-12-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
Where it is running
- Omega Research Consultants LLC — DeBary, Florida, United States
- Hassman Research Institute — Berlin, New Jersey, United States
- Wake Research Associates Oncology — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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