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| ID | Type | Description | Link |
|---|---|---|---|
| CA43815 | Other Identifier | Celerion Protocol Number | |
| MK-1084-009 | Other Identifier | MSD |
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The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called calderasib. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without calderasib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Midazolam and Digoxin | Experimental | Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1. |
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| Period 2: Calderasib, Midazolam, and Digoxin | Experimental | A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first calderasib dosing in Period 2. Participants will receive calderasib once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Midazolam | Blood samples will be collected to determine the AUC0-inf of midazolam. | Predose and at designated timepoints up to 24 hours postdose |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Midazolam | Blood samples will be collected to determine the AUC0-last of midazolam. | Predose and at designated timepoints up to 24 hours postdose |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of Midazolam | Blood samples will be collected to determine the AUC0-24hr of midazolam. | Predose and at designated timepoints up to 24 hours postdose |
| Maximum Plasma Concentration (Cmax) of Midazolam | Blood samples will be collected to determine the Cmax of midazolam. | Predose and at designated timepoints up to 24 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of Midazolam | Blood samples will be collected to determine the Tmax of midazolam. | Predose and at designated timepoints up to 24 hours postdose |
| Apparent Terminal Half-life (t1/2) of Midazolam | Blood samples will be collected to determine the t1/2 of midazolam. | Predose and at designated timepoints up to 24 hours postdose |
| Apparent Clearance (CL/F) of Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24hr of Calderasib | Blood samples will be collected to determine the AUC0-24hr of calderasib. | Predose and at designated timepoints up to 24 hours postdose |
| AUC0-Last of Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib. |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key 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 |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Oral administration |
|
| Digoxin | Drug | Oral administration |
|
Blood samples will be collected to determine the CL/F of midazolam.
| Predose and at designated timepoints up to 24 hours postdose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam | Blood samples will be collected to determine the Vz/F of midazolam. | Predose and at designated timepoints up to 24 hours postdose |
| AUC0-Inf of Digoxin | Blood samples will be collected to determine the AUC0-inf of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| AUC0-Last of Digoxin | Blood samples will be collected to determine the AUC0-last of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| AUC0-24hr of Digoxin | Blood samples will be collected to determine the AUC0-24hr of digoxin. | Predose and at designated timepoints up to 24 hours postdose |
| Cmax of Digoxin | Blood samples will be collected to determine the Cmax of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| Tmax of Digoxin | Blood samples will be collected to determine the Tmax of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| t1/2 of Digoxin | Blood samples will be collected to determine the t1/2 of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| CL/F of Digoxin | Blood samples will be collected to determine the CL/F of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| Vz/F of Digoxin | Blood samples will be collected to determine the Vz/F of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| Predose and at designated timepoints up to 24 hours postdose |
| Cmax of Calderasib | Blood samples will be collected to determine the Cmax of calderasib. | Predose and at designated timepoints up to 24 hours postdose |
| C24 of Calderasib | Blood samples will be collected to determine the Cmax of calderasib. | Predose and at designated timepoints up to 24 hours postdose |
| Tmax of Calderasib | Blood samples will be collected to determine the Tmax of calderasib. | Predose and at designated timepoints up to 24 hours postdose |
| t1/2 of Calderasib | Blood samples will be collected to determine the t1/2 of calderasib. | Predose and at designated timepoints up to 24 hours postdose |
| Cmax Accumulation Ratio of Calderasib | Blood samples will be collected to determine the Cmax accumulation ratio of calderasib. The accumulation ratio is the ratio of Predose Cmax to the 24 hour Cmax | Predose and at designated timepoints up to 24 hours postdose |
| AUC0-24 Accumulation Ratio of Calderasib | Blood samples will be collected to determine the AUC0-24 accumulation ratio of calderasib. The accumulation ratio is the ratio of Predose AUC0-24 to the 24 hour AUC0-24. | Predose and at designated timepoints up to 24 hours postdose |
| Amount of Drug Excreted in Urine from Time 1 to Time 2 (Aet1-t2) of Digoxin | Urine samples will be collected to determine the Aet1-t2 of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| Total Amount of Drug Excreted in Urine (Ae) of Digoxin | Urine samples will be collected to determine the Ae of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| Fraction of Unchanged Digoxin in Urine (Fe) | Urine samples will be collected to determine the Fe of digoxin. | Predose and at designated timepoints up to 120 hours postdose |
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a 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 1 month |
| Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported. | Up to approximately 1 month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |