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 being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial assessed its relative bioavailability in healthy participants, meaning the drug is being evaluated for how it is absorbed and processed by the body.
M7583 is being developed by Merck KGaA, a German science and technology company. The company's stock is traded over the counter under the ticker MKGAF. Merck KGaA is conducting early-stage clinical research on this small molecule drug candidate.
M7583 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. Its single completed trial was a Phase 1 study, and no active trials are currently listed, indicating the program is at an early stage.
M7583 has one completed clinical trial, registered as NCT03298379. This Phase 1 study, titled 'M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule,' enrolled 18 healthy participants in Germany. The trial was controlled and randomized but not double-blind, and it evaluated the drug's bioavailability.
No alternative names for M7583 have been disclosed in the available information. The drug is identified solely by its code name M7583 in clinical trial registrations and development records.