Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam (NCT02082665) | Clinical Trial Compass
CompletedPhase 1
Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam
United States, Spain6 participantsStarted 2015-02-19
Plain-language summary
This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose of dabrafenib 150 mg), and Day 22 (during repeat dose dabrafenib 150 mg twice daily \[BID\]). Dabrafenib 150 mg BID will be administered from Day 8 to Day 23. Blood samples for PK analysis will be obtained over 32 hours post-dose on Day 1, Day 8, and Day 22. The last dose of dabrafenib will be taken in the morning of Day 23 and the last blood sample in the evening of Day 23. Subjects will be considered to have completed the study once the 32 hour PK sample has been collected on Day 23. Once they have completed the study, eligible subjects may have the option to enter study BRF114144, an open-label roll-over study of dabrafenib (no follow-up visit required) and continue receiving dabrafenib.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Signed, written informed consent.
* BRAF V600 mutation-positive tumor: as confirmed by a Clinical Laboratory Improvement Amendments (CLIA) approved local laboratory or equivalent.
* Male or female between 18 to 65 years of age, inclusive, at the time of signing the informed consent form;
* Capable of compliance with the requirements and restrictions listed in the consent form;
* Body weight \>= 45 kilogram (kg) and a body mass index \>= 19 kilogram per squaremeter (kg/m\^2)and \<40 kg/m\^2 (inclusive);
* Able to swallow and retain orally administered medication
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1. NOTE: Subjects with a performance status of 2 can be enrolled if the subject's confinement to bed and inability to carry out work activities is due solely to cancer-related pain, as assessed by the Investigator.
* Adequate baseline organ function defined as: absolute neutrophil count \>= 1.2 x 10\^9/Liter (L); hemoglobin\>=9 gram per deciliter (g/dL); platelets \>= 75 x 10\^9/L; prothrombin time /international normalized ratio and partial thromboplastin time =\<1.3 x ULN; serum bilirubin=\<1.5 times upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase =\<2.5 times ULN; serum creatinine=\<1.5 mg/dL or calculate creatinine clearance \>= 50 milliliter per minute; Left ventricular ejection fraction\>= lower limit of normal by echocardiography.
* Women of child-bearing potential must be willing to p…
What they're measuring
1
Pharmacokinetics (PK) parameter of rosuvastatin and midazolam
Timeframe: Day 1, Day 8 (initiation of dabrafenib dosing) and Day 22 (steady state)