4 results
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
Establish the technical feasibility and safety of implantation of the investigational device, adjustment of the investigational device post-implantation and the ability of the investigational device to reduce mitral valve regurgitation.
The primary objective of this clinical trial is to evaluate the safety and effectiveness of the AltaSeal® implants to provide bilateral mechanical occlusion of the fallopian tubes resulting prevention of pregnancy.
Primary Objectives:Part 1- Estimate the relative bioavailability of the tablet formulation of TAK-931 in reference to the PIC formulation.Part 2- Assess the effect of a high-fat meal on the single dose PK of TAK-931 administered as the tablet…