13 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…
The primary objective is to the safety of long term administration of etrasimod in subjects with moderately to severely active UC. The secondary objective is to assess the the long-term efficacy of etrasimod in subjects with moderately to severely…
Primary objective:To assess the bioequivalence of single-dose velpatasvir administered as a fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) when given with cola + omeprazole 40mg (test 1/trt A) compared to velpatasvir…
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;…
Primary objective:To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VELSecondary objective:To evaluate the safety and tolerability of crushed SOF/VEL tablets in…
The purpose of the study is to investigate the effect of etrasimod on the values of specific ECG parameters. Importantly, the study will assess whether there is a prolongation of the QT interval following etrasimod treatment. When the QT interval is…
- 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…
Main objective:*To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active Crohn's disease (CD).*To select an oral etrasimod dose, based on efficacy and…
Primary:* To evaluate the effects of etrasimod on esophageal eosinophilia in adult subjects with active eosinophilic esophagitis (EoE)* To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo in adult subjects with active…
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.
The primary objective is to assess the efficacy of etrasimod when administered for 12 weeks on clinical remission in subjects with moderately to severely active ulcerative colitis (UC). The secondary objective is to assess the efficacy of etrasimod…
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…
The primary objective is to assess the efficacy of etrasimod on clinical remission in subjects with moderately to severely active ulcerative colitis (UC) after 12 and 52 weeks of treatment. The secondary objective is to assess the efficacy of…