Healthy, Renal 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 (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
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 85 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Body Mass Index (BMI) between 18 and 40 kg/m\^2, inclusive * On a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide | Day 28 predose and 1, 3, 8, and 24 hours postdose | The AUC0-24 of enlicitide in plasma is reported. |
| Maximum Plasma Concentration (Cmax) of Enlicitide | Day 28 predose and 1, 3, 8, and 24 hours postdose | The Cmax of enlicitide is reported. |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide in Plasma | Day 28 predose and 1, 3, 8, and 24 hours postdose | The Tmax of plasma enlicitide is reported. |
| Apparent Plasma Clearance at Steady State (CLss/F) of Enlicitide | Day 28 predose and 1, 3, 8, and 24 hours postdose | CLss/F of enlicitide is reported. |
| Apparent Plasma Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide | Day 28 predose and 1, 3, 8, and 24 hours postdose | The plasma Vz/F of enlicitide was to be reported. Vz/F was not reported, because blood for PK was only collected for 24 hours post dose at steady state (Day 28), thus the terminal phase could not be characterized, and Vz/F could not be calculated. |
| Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 42 days | The number of participants with ≥1 AE is reported. 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. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 28 days | 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. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Recruitment details
Adult male and female participants on background statin therapy who were either healthy, or had severe renal impairment, were recruited.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.6 Years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 12 |
| other Total, other adverse events | 4 / 15 | 2 / 12 |
| serious Total, serious adverse events | 3 / 15 | 0 / 12 |
Outcome results
None listed