Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Calderasib OCT · 1 trial · 1 indication
Blood samples will be collected to determine the AUC0-last of calderasib.
Blood samples will be collected to determine the AUC0-inf of calderasib.
Blood samples will be collected to determine the AUC0-24 of calderasib.
Blood samples will be collected to determine the Cmax of calderasib.
Blood samples will be collected to determine the C24 of calderasib.
Blood samples will be collected to determine the Tmax of calderasib.
Blood samples will be collected to determine the t1/2 of calderasib.
Blood samples will be collected to determine the CL/F of calderasib.
Blood samples will be collected to determine the Vz/F of calderasib.
Blood samples will be collected to determine the tlag of calderasib.
| Arm | Type | Description |
|---|---|---|
| Part 1 Calderasib Treatment A | EXPERIMENTAL | Participants will be administered low dose calderasib as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) |
| Part 1 Calderasib Treatment B | EXPERIMENTAL | Participants will be administered low dose calderasib as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) |
| Part 2 Calderasib Treatment C | EXPERIMENTAL | Participants will be administered higher dose calderasib as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast) |
| Part 2 Calderasib Treatment D | EXPERIMENTAL | Participants will be administered higher dose calderasib as a FCT on Day 1 under fed conditions (after a high-fat meal) |
| Name | Type | Description |
|---|---|---|
| Calderasib OCT | DRUG | Oral tablet |
| Calderasib FCT | DRUG | Oral tablet |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history or presence of a clinically significant me...
Calderasib OCT is an investigational small molecule being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development. The drug has been studied in healthy adult participants to evaluate the effect of formulation and food on its pharmacokinetics.
Calderasib OCT is being studied in healthy volunteers as part of early clinical development. The completed Phase 1 trial assessed how different formulations and food intake affect the drug's behavior in the body. It is not yet approved for any medical condition and remains investigational.
Calderasib OCT is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker MRK. The company is conducting clinical trials to evaluate the drug's properties in healthy participants.
Calderasib OCT is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 52 healthy adult participants in the United States. The drug has received a Breakthrough Therapy designation from the FDA, though it remains investigational and not yet approved.
Calderasib OCT has one completed clinical trial, NCT06942741, titled 'A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011).' This Phase 1 study enrolled 52 healthy adults in the United States and was a controlled, randomized trial.
Yes, Calderasib OCT is also known as MK-1084. The clinical trial NCT06942741 refers to the drug as Calderasib (MK-1084), indicating that both names refer to the same investigational compound being developed by Merck & Company, Inc.