Phase 1
N=14
A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)
Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04676425 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189 — 5600; 4710 h*nmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Elpipodect (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189 |
5600; 4710 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of MK-8189 |
194; 158 | — |
| SECONDARY Number of Participants Who Experience One or More Adverse Events (AEs) |
4; 0 | — |
| SECONDARY Number of Participants Who Discontinue From the Study Due to an AE |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent)
- Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention
- (For hepatically impaired participants) Has a diagnosis of chronic (>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment
Exclusion Criteria
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
- Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies
- Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food
- Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit
- Consumes greater than 3 glasses of alcoholic beverages per day
- Consumes greater than 6 servings (1 serving is ~120 mg of caffeine) caffeinated beverages per day
- (For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study
Data sourced from ClinicalTrials.gov (NCT04676425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.