6 results
Primary Objective: To assess the level of agreement between ACC variables (amplitude, latency) in CI users and the FDT perceived by the same CI users.Secondary Objectives: • To assess correlations between speech perception and ACC variables, and…
Validation of the Eleveld PKPD model, both the pharmacokinetic component (plasma concentrations) and the pharmacodynamic component (effect: bispectral index (BIS) and predicted effect-site concentrations).
Primary• To assess the safety and tolerability in healthy volunteers of nizaracianine administered IV in three divided dosesSecondary• To perform pharmacokinetic analyses of blood and urine• To determine if bolus injection of nizaracianine enables…
Primary:* * To determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed objective response rate (ORR) in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy…
Study Objective(s):Primary-To compare the overall survival (OS) of subjects with locally advanced or metastatic urothelialcancer treated with enfortumab vedotin (EV) to the OS of subjects treated with chemotherapySecondary-To compare progression-…
Primary Part 1:-To evaluate ORR in participants treated with MK-4280A plus EV (Arm A), MK-7684A plus EV (Arm B), and pembrolizumab plus EV(Arm C) per RECIST 1.1 by BICR.- To evaluate the safety and tolerability in participants treated with MK-4280A…