NCT06575933 - A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009) | Crick | Crick

A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009)

Phase 1CompletedNCT06575933

Merck Sharp & Dohme LLC28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

28

Conditions

Non-small Cell Lung Cancer

Interventions

Oral administration

Oral administration

Oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs) * Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study * Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds

Locations (1)

Celerion ( Site 0001)

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Apparent Clearance (CL/F) of Midazolam

Blood samples will be collected to determine the CL/F of midazolam.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Data from ClinicalTrials.gov

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Secondary Outcomes

AUC0-24hr of Calderasib

Blood samples will be collected to determine the AUC0-24hr of calderasib.

Time frame: 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.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Cmax of Calderasib

Blood samples will be collected to determine the Cmax of calderasib.

Time frame: Predose and at designated timepoints up to 24 hours postdose

C24 of Calderasib

Blood samples will be collected to determine the Cmax of calderasib.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Tmax of Calderasib

Blood samples will be collected to determine the Tmax of calderasib.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to approximately 1 month