Approval Probability
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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 developed by Merck & Company, Inc. (ticker MRK). It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease indications being explored for PT2385 have not been publicly disclosed.
PT2385 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical program evaluating PT2385.
PT2385 is in Phase 1 clinical development. It is an investigational agent and is not approved by the FDA. The Phase 1 program includes one completed trial, and there are currently no active trials of PT2385 listed.
PT2385 has been evaluated in one completed Phase 1 trial, NCT02553356, titled PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers. The trial enrolled 16 healthy female volunteers aged 18 years and older in the United States and used a controlled, randomized design.
NCT02553356 was a Phase 1 food effect study of PT2385 conducted in healthy volunteers. It enrolled 16 participants, all female and at least 18 years old, in the United States. The trial was controlled and randomized, was not double blind, and has been completed.