Approval Probability
TA Base Rate
Adjusted LOA
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Also known as MK-1084 OCT
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 developed by Merck & Company, Inc. (ticker MRK). It is in Phase 1 clinical development. The therapeutic indication for Calderasib OCT has not been disclosed. It is also known as MK-1084.
Calderasib OCT is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program for this investigational small molecule.
Calderasib OCT is in Phase 1 clinical development. It is an investigational drug and is not approved. One Phase 1 trial has been completed, and no trials are currently active.
Calderasib OCT has been studied in one completed Phase 1 trial, NCT06942741, titled a study to evaluate the effect of formulation and food on Calderasib (MK-1084) in healthy adult participants. That trial enrolled 52 healthy volunteers in the United States and was controlled and randomized.
Yes, Calderasib OCT is also known as MK-1084. The completed Phase 1 trial NCT06942741 refers to the drug as Calderasib (MK-1084), so both names identify the same investigational small molecule being developed by Merck & Company, Inc.