A Phase 1 interventional study of Elpipodect in Hepatic Impairment, sponsored by Merck Sharp & Dohme LLC. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to compare the pharmacokinetics (PK) of elpipodect in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of elpipodect in participants with mild hepatic impairment to healthy participants.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with hepatic impairment will receive a single dose of elpipodect 4 mg orally on Day 1.
Drug: Elpipodect
Healthy participants will receive a single dose of MK-8189 4 mg orally on Day 1.
Drug: Elpipodect
Administered at a dose of 4 mg via oral tablet
Also known as: MK-8189
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189
AUC0-inf is a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood samples collected pre and post-dose at multiple timepoints were used to estimate AUC0-inf following MK-8189 administration. Geometric least-squares mean and confidence intervals for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values.
Time frame: Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy participants); 60, 84, 108 and 120 hours post-dose (hepatic impairment participants)
Maximum Observed Plasma Concentration (Cmax) of MK-8189
Cmax is the maximum concentration of MK-8189 observed in plasma. Blood samples collected pre and post-dose at multiple timepoints were used to estimate Cmax following MK-8189 administration. Geometric least-squares mean and confidence intervals of Cmax were calculated using a linear fixed effects model performed on natural log-transformed values.
Time frame: Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy); 60, 84, 108 and 120 hours post-dose (hepatic impairment)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.
Time frame: Up to approximately 15 days
Number of Participants Who Discontinue From the Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Time frame: Up to approximately 15 days
As prespecified in the protocol, the safety and pharmacokinetic (PK) data from Part 1 of the study, comparing participants with moderate hepatic impairment to healthy participants, were reviewed after completion of Part 1. Per protocol, a decision was made to not conduct Part 2 of the study, comparing participants with mild hepatic impairment to healthy participants.
| Milestone | Moderate Hepatic Impairment Participants | Healthy Participants |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
AUC0-inf is a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood samples collected pre and post-dose at multiple timepoints were used to estimate AUC0-inf following MK-8189 administration. Geometric least-squares mean and confidence intervals for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values.
| h*nmol/L | Moderate Hepatic Impairment Participants | Healthy Participants |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189 | 5600 (3020 to 10400) | 4710 (3340 to 6660) |
Cmax is the maximum concentration of MK-8189 observed in plasma. Blood samples collected pre and post-dose at multiple timepoints were used to estimate Cmax following MK-8189 administration. Geometric least-squares mean and confidence intervals of Cmax were calculated using a linear fixed effects model performed on natural log-transformed values.
| nmol/L | Moderate Hepatic Impairment Participants | Healthy Participants |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of MK-8189 | 194 (127 to 296) | 158 (131 to 191) |
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.
| Participants | Moderate Hepatic Impairment Participants | Healthy Participants |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | 4 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
| Participants | Moderate Hepatic Impairment Participants | Healthy Participants |
|---|---|---|
| Number of Participants Who Discontinue From the Study Due to an AE | 0 | 0 |
Collected over Up to approximately 15 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate Hepatic Impairment Participants | 0/7 (0%) | 0/7 (0%) | 4/7 (57.1%) |
| Healthy Participants | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Event | Moderate Hepatic Impairment Participants | Healthy Participants |
|---|---|---|
| VomitingGastrointestinal disorders | 2/7 | 0/7 |
| FallInjury, poisoning and procedural complications | 1/7 | 0/7 |
| Decreased appetiteMetabolism and nutrition disorders | 1/7 | 0/7 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 1/7 | 0/7 |
| DizzinessNervous system disorders | 1/7 | 0/7 |
| HeadacheNervous system disorders | 1/7 | 0/7 |
| Affect labilityPsychiatric disorders | 1/7 | 0/7 |
| AnxietyPsychiatric disorders | 1/7 | 0/7 |
| Hot flushVascular disorders | 1/7 | 0/7 |
| HypotensionVascular disorders | 1/7 | 0/7 |
| Age, Continuous(Years) | Moderate Hepatic Impairment Participants | Healthy Participants | Total |
|---|---|---|---|
| Mean | 55.7 ± 8.2 | 57.1 ± 8.0 | 56.4 ± 7.8 |
| Sex: Female, Male(Participants) | Moderate Hepatic Impairment Participants | Healthy Participants | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 5 | 5 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Moderate Hepatic Impairment Participants | Healthy Participants | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 4 | 8 |
| Not Hispanic or Latino | 3 | 3 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Moderate Hepatic Impairment Participants | Healthy Participants | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 7 | 6 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Merck Sharp & Dohme LLC