A Phase I, Randomized, Open-label, Multi-center, Two Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of RO5185426, Followed by Administration of 960 mg RO5185426 Twice Daily to BRAF V600E Positive Metastatic Melanoma Patients
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of food (high fat meal) on the pharmacokinetics of vemurafenib: AUC, C max, C min, T max, t1/2, k el
21 days
No
Clinical Trials
Study Director
Hoffmann-La Roche
United States: Food and Drug Administration
NP25396
NCT01264380
January 2011
September 2013
Name | Location |
---|---|
Bettendorf, Iowa 52722 | |
Fountain Valley, California 92708 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Lebanon, New Hampshire |