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

Phase 1CompletedNCT06626464

Merck Sharp & Dohme LLC6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C]ElpipodectDRUG

Oral administration

Eligibility

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

Medical Language ↔ Plain English

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.

Locations (1)

Labcorp Clinical Research Unit Inc. (Site 0001)

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

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

Time frame: Predose and postdose up to 24 hours

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

Blood samples will be collected to determine the AUClast of elpipodect.