Hepatic Insufficiency, Hepatic Impairment
Conditions
Brief summary
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called enlicitide from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health. This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.
Interventions
DRUGEnlicitide
Oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: All participants: * Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study * Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2 Participants with moderate or mild HI: * Diagnosis of chronic (\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause. * Is generally in good health with the exception of HI. Healthy Control Participants: * Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide | Pre-dose and at designated time points up to 168 hours post dose | AUC0-inf of enlicitide in plasma will be determined. |
| Part 1: Maximum concentration (Cmax) of enlicitide | Predose, and at designated timepoints up to 168 hours post-dose | Cmax of enlicitide in plasma will be determined |
| Part 2: AUC 0-inf of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | AUC 0-inf of enlicitide in plasma will be determined |
| Part 2: Cmax of enlicitide | Predose, and at designated timepoints up to 168 hours post-dose | Cmax of enlicitide in plasma will be determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Apparent clearance (CL/F) of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | CL/F of enlicitide in plasma will be determined |
| Part 1: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | Vz/F of enlicitide in plasma will be determined |
| Part 1: Number of participants who experience one or more adverse events (AEs) | Up to approximately 6 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Part 1: Number of participants who discontinue study intervention due to an AE | Up to approximately 6 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Part 2: AUC0-24 of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | AUC0-24 of enlicitide in plasma will be determined. |
| Part 2: AUC0-last of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | AUC0-last of enlicitide in plasma will be determined |
| Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | AUC0-24 of enlicitide in plasma will be determined. |
| Part 2: t1/2 of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | t1/2 of enlicitide in plasma will be determined |
| Part 2: CL/F of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | CL/F of enlicitide in plasma will be determined |
| Part 2: Vz/F of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | Vz/F of enlicitide in plasma will be determined |
| Part 2 Number of participants who experience one or more adverse events (AEs) | Up to approximately 6 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Part 2: Number of participants who discontinue study intervention due to an AE | Up to approximately 6 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Part 2: Tmax observed plasma drug concentration of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | Tmax of enlicitide in plasma will be determined |
| Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | AUC0-last of enlicitide in plasma will be determined |
| Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | Tmax of enlicitide in plasma will be determined |
| Part 1: Apparent terminal half-life (t1/2) of enlicitide | Pre-dose and at designated timepoints up to 168 hours post dose | t1/2 of enlicitide in plasma will be determined |
Countries
United States
Outcome results
None listed