Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:3/28/2019
Start Date:December 19, 2016
End Date:February 4, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase I, Open Label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics of Dabrafenib in Healthy Subjects With Normal Renal Function and Subjects With Impaired Renal Function

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.


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.
We found this trial at
4
sites
Berlin, New Jersey
Principal Investigator: Michael Hassman
Phone: 856-753-7335
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Debary, Florida
Principal Investigator: Kwabena Ayesu
Phone: 386-668-4202
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Debary, FL
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Los Angeles, California 90017
Principal Investigator: Michael Guice
Phone: 213-481-7142
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Los Angeles, CA
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3100 Duraleigh Road
Raleigh, North Carolina 27612
Principal Investigator: Wayne L Harper
Phone: 919-781-2514
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Raleigh, NC
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