5 results
PRIMARYTo demonstrate an effect of recAP on 28-day all-cause mortality.SECONDARY1. To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).2. To investigate the effect of recAP on use of organ support, i.e., mechanical…
Primary:* Evaluate the safety and tolerability of ALKS 7119 following oral administration of multiple ascending doses of ALKS 7119 in healthy male and female adultsSecondary:* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119…
To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
The purpose of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered a GONAL-f® dose determined according to a calculator system versus a given standard GONAL-f® dose of 150 International Unit…