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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-011 | Other Identifier | MSD |
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This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib OCT | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib | Blood samples will be collected to determine the AUC0-inf of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib | Blood samples will be collected to determine the AUC0-24 of calderasib. | At designated timepoints (up to 24 hours postdose) |
| Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib | Blood samples will be collected to determine the Cmax of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24) | Blood samples will be collected to determine the C24 of calderasib. | At designated timepoints (up to 24 hours postdose) |
| Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib | Blood samples will be collected to determine the Tmax of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported | Up to approximately 7 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Celerion ( Site 0001) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
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| Merck Clinical Trials Information | View source |
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| Calderasib FCT | Drug | Oral tablet |
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| Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib | Blood samples will be collected to determine the t1/2 of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib | Blood samples will be collected to determine the CL/F of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib | Blood samples will be collected to determine the Vz/F of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Part 2: Plasma Lag Time (tlag) of Calderasib | Blood samples will be collected to determine the tlag of calderasib. | At designated timepoints (up to approximately 2 days postdose) |
| Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue from the study treatment due to an AE will be reported. | Up to approximately 1 week |