Healthy
Conditions
Brief summary
The purpose of this study is to learn what happens to elpipodect in a healthy person's body over time.
Interventions
DRUG[14C]Elpipodect
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Elpipodect | Predose and postdose up to 24 hours | Blood samples will be collected to determine the AUC0-24 of elpipodect. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Elpipodect | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the AUClast of elpipodect. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Elpipodect | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the AUC0-inf of elpipodect. |
| Maximum Concentration (Cmax) of Elpipodect | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the Cmax of elpipodect. |
| Apparent Half Life (t½) of Elpipodect | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the t1/2 of elpipodect. |
| Time to Reach Maximum Concentration (Tmax) of Elpipodect | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the Tmax of elpipodect. |
| Amount Excreted (Ae) in Urine of Elpipodect | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the Ae of elpipodect |
| %Dose Excreted in Urine of Elpipodect | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the %dose of elpipodect |
| Amount Excreted (Ae) in Feces of Elpipodect | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the Ae of elpipodect. |
| %Dose Excreted in Feces of Elpipodect | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the %dose of elpipodect. |
| Metabolites in Plasma of Elpipodect | Predose and at designated timepoints up to Day 15 | Blood samples will be collected to determine the metabolites of elpipodect. |
| Metabolites in Urine of Elpipodect | Predose and at designated timepoints up to Day 15 | Urine samples will be collected to determine the metabolites of elpipodect. |
| Metabolites in Feces of Elpipodect | Predose and at designated timepoints up to Day 15 | Feces samples will be collected to determine the metabolites of elpipodect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | Up to ~ 28 days | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
| Number of Participants Discontinuing Study Treatment due to an AE | Up to ~ 28 days | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed