28 results
There is no formal primary research hypothesis to be statistically tested. The purpose of this study is to evaluate the pharmacokinetics, the pharmacodynamics, the safety profile and tolerability following multiple oral doses of apixaban in…
Primary :To evaluate the prothrombin time (PT) in healthy volunteers treated with edoxaban alone or preceded by apixaban.Secondary : To assess the effect of edoxaban alone or preceded by apixaban on additional pharmacodynamic (PD) assays: activated…
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…
* to evaluate the safety and tolerability of Lu AF90103 following single ascending intravenous (i.v.) doses* to investigate the pharmacokinetics (PK) of Lu AF90103 (prodrug) and Lu AF88361 (drug) in plasma and cerebrospinal fluid (CSF) following…
Primary objective: - To evaluate the systemic absorption and pharmacokinetics of topically applied NT-077 Secondary objectives: - To evaluate the safety and tolerability of topically applied NT-077- To evaluate the pharmacodynamic effect on sweat…
Primary objective:• To assess the mass balance of nanatinostat (ie, evaluate clearance mechanisms of nanatinostat and drug-related metabolites) following a single oral dose of [14C]-nanatinostat in patients with advanced cancer.Secondary objectives…
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
Part 1:Primary objective:• To estimate the relative bioavailability of two THB001 formulations in healthy adults.Secondary objectives:• To determine the single-dose pharmacokinetics (PK) of THB001•HCl salt and THB001 free base formulations in…
Primary ObjectiveTo assess the tolerability and safety of single ascending oral doses of PHA-022121 administered after a standard meal and of a single 40 mg dose under fasted conditions in healthy adult subjects.To assess the PK characteristics of…
The aim of this study is to assess whether oral apixaban in non-inferior to the subcutaneous LMWH dalteparin for the treatment of newly diagnosed proximal DVT and/or PE in patients with cancer.
Dual Primary Objectives:* To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTHmajor or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI withplanned…
Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…
Primary objective: To evaluate the safety and tolerability of single ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.Secondary objective: To evaluate OMN6 PK in plasma following single ascending i.v. doses in healthy young…
Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
To investigate non-inferiority regarding the safety of a 6% HES solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.
Primary objective:• To evaluate the safety and tolerability profile of single intravenous doses of AST-004 given as a short loading intravenous infusion followed by a 6-hour continuous intravenous (IV) infusion in healthy adult subjects.Secondary…