9 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.
Part 1:The purpose of Part 1 of the study is to investigate how much of the OZ439 compound is absorbed into, distributed in, and eliminated from the body (this is called pharmacokinetics) when administered orally as compared to an intravenous (iv;…
This phase II/III controlled multicenter trial will investigate the ability of individualized chemotherapy to improve the objective response rate of *triple-negative* breast cancer (estrogen receptor and progesterone receptor-negative, no HER2…
The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to upfront repeat local treatment in patients with at least one locally treatable recurrent CRLM in the absence of…
The primary objective of this study is to compare overall survival rates of CRC patients with multi-organ metastases with indication for first line palliative systemic treatment for mCRC, randomized for treatment with combination chemotherapy or…
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…
The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…