CompletedPhase 1

A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)

United States8 participantsStarted 2024-06-26

Plain-language summary

The purpose of this study is to learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body.

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization. * Has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at screening Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. * Has a history of cancer.

What they're measuring

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Maximum Concentration (Cmax) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Concentration at 24 hours postdose (C24) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Time to Reach Maximum Concentration (Tmax) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Apparent Half Life (t½) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Trial details

NCT IDNCT06687759

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-07

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Maximum Concentration (Cmax) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Concentration at 24 hours postdose (C24) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Time to Reach Maximum Concentration (Tmax) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15

Apparent Half Life (t½) of plasma Calderasib

Timeframe: Predose and at designated timepoints up to Day 15