Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M7583 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| First M7583 Tablet:Fasted, Then PiC:Fasted, Then Tablet:Fed | EXPERIMENTAL | - |
| First M7583 PiC:Fasted, Then Tablet:Fasted, Then Tablet:Fed | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M7583 | DRUG | Subject will receive either M7583 PiC or M7583 tablet formulation orally under fasted conditions in part 1 followed by M7583 tablet formulation under fed condition in part 2 of the study. |
Inclusion Criteria: * Adult males and females between 18 and 55 years of age (inclusive) with total body weight between 50.0 and 100.0 kilogram (kg) (inclusive) and body mass index (BMI) between 19.0 and 30.0 kilogram per meter square (kg/m2) (inclusive) at the time of the Screening examination. * ...
M7583 is an investigational small molecule developed by Merck KGaA. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in Germany. The specific disease or condition it is intended to treat has not been disclosed.
M7583 is being developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the Phase 1 trial of the compound conducted in Germany.
M7583 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA.
M7583 has been evaluated in one completed Phase 1 trial, NCT03297983, titled M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule. The trial enrolled 18 healthy adult volunteers in Germany and used a controlled, randomized design without double blinding.
Yes. The Phase 1 trial of M7583, NCT03297983, was a randomized, controlled study. It was not double blinded. The trial enrolled 18 healthy volunteers aged 18 years and older in Germany and has been completed.