CompletedPhase 1

A Study of Elpipodect (MK-8189) Human Absorption, Metabolism, and Excretion in Healthy Male Participants (MK-8189-010)

United States6 participantsStarted 2022-05-13

Plain-language summary

The purpose of this study is to learn what happens to elpipodect in a healthy person's body over time.

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, VS measurements, and ECGs performed before randomization. * Has a BMI ≥19 and ≤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 0 to 24 hours (AUC0-24) of Elpipodect

Timeframe: Predose and postdose up to 24 hours

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

Timeframe: Predose and at designated timepoints up to Day 15

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

Timeframe: Predose and at designated timepoints up to Day 15

Maximum Concentration (Cmax) of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15

Apparent Half Life (t½) of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15

Time to Reach Maximum Concentration (Tmax) of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15

Amount Excreted (Ae) in Urine of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15

Trial details

NCT IDNCT06626464

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-08

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 0 to 24 hours (AUC0-24) of Elpipodect

Timeframe: Predose and postdose up to 24 hours

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

Timeframe: Predose and at designated timepoints up to Day 15

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

Timeframe: Predose and at designated timepoints up to Day 15

Maximum Concentration (Cmax) of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15

Apparent Half Life (t½) of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15

Time to Reach Maximum Concentration (Tmax) of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15

Amount Excreted (Ae) in Urine of Elpipodect

Timeframe: Predose and at designated timepoints up to Day 15