Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PT2385 · 1 trial · 1 indication
Peak Plasma Concentration (Cmax) will be assessed in both the fasting and non-fasting conditions and compared.
| Arm | Type | Description |
|---|---|---|
| Fasted | EXPERIMENTAL | PT2385 taken after fasting. |
| Non-Fasting | EXPERIMENTAL | PT2385 taken after eating a high calorie meal. |
| Name | Type | Description |
|---|---|---|
| PT2385 | DRUG | - |
Inclusion Criteria: * Female between 18 and 45 years of age; * If of childbearing potential, willing to practice methods of birth control; * If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial; * Has...
PT2385 is an investigational small molecule being developed by Merck & Company, Inc. (NYSE: MRK). It is being studied in a Phase 1 clinical trial in healthy volunteers. The drug is not approved and remains in clinical development.
PT2385 is being studied for use in healthy volunteers. The completed Phase 1 trial, NCT02553356, evaluated the food effect of PT2385 in healthy female participants aged 18 years and older in the United States.
PT2385 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company sponsored the Phase 1 clinical trial of the drug.
PT2385 is in Phase 1 clinical development. One Phase 1 trial, NCT02553356, has been completed. The drug is investigational and has not been approved for any use.
PT2385 has one completed Phase 1 clinical trial, NCT02553356, titled "PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers." The trial enrolled 16 healthy female participants in the United States and was a controlled, randomized study.