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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-020 | Other Identifier | MSD |
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The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease [ESRD]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.
Panel C included participants with ESRD. No urine samples could be obtained on Panel C participants and hence no pharmacokinetic (PK) analysis could be performed for Panel C participants as pre-specified in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: Moderate Renal Impairment (RI) | Experimental | Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1 |
|
| Panel B: Severe RI | Experimental | Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1 |
|
| Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD) | Experimental | Participants receive Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16. |
|
| Panel D: Healthy Controls | Experimental | Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide Decanoate | Drug | Oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate | AUC0-inf was a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood for plasma samples was collected at pre-specified timepoints to determine the AUC0-inf of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUC0-inf. Per protocol, mean AUC0-inf was reported. | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
| AUC From Time 0 to Last Measurable Concentration (AUClast) of Enlicitide Decanoate | AUClast was defined as the area under the concentration-time curve of enlicitide decanoate from time zero to last measurable concentration. Blood for plasma samples was collected at pre-specified timepoints to determine the AUClast of enlicitide decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUClast. Per protocol, mean AUClast was reported. | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
| Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate | Cmax was defined as the maximum or peak concentration of enlicitide decanoate observed after its administration. Blood for plasma samples was collected at pre-specified time points to determine the Cmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Cmax. Per protocol, mean Cmax was reported. | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate |
| Measure | Description | Time Frame |
|---|---|---|
| Panel C: Dialysate Clearance (CLd) of Enlicitide Decanoate | CLd was the measure of the amount of enlicitide decanoate cleared from plasma via dialysis. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean CLd. | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, Hallandale Beach ( Site 0003) | Hallandale | Florida | 33009 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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All allocated participants. Panel C included participants with End-Stage Renal Disease (ESRD). No urine samples could be obtained on Panel C participants and hence no pharmacokinetic (PK) analysis could be performed for Panel C participants as pre-specified in the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A: Moderate Renal Impairment (RI) | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| FG001 | Panel B: Severe RI | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| FG002 | Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD) | Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16. |
| FG003 | Panel D: Healthy Controls | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All allocated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A: Moderate Renal Impairment (RI) | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| BG001 | Panel B: Severe RI | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate | AUC0-inf was a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood for plasma samples was collected at pre-specified timepoints to determine the AUC0-inf of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUC0-inf. Per protocol, mean AUC0-inf was reported. | All allocated participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for AUC0-inf. | Posted | Geometric Mean | 95% Confidence Interval | hr*nmol/Liter | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
|
Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel A: Moderate Renal Impairment (RI) | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2023 | Dec 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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|
Tmax was defined as the time required for a study drug to reach maximum concentration in plasma. Blood for plasma samples was collected at pre-specified time points to determine the Tmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Tmax. Per protocol, mean Tmax was reported. |
| Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
| Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate | Half-life (t1/2) was defined as the time required for plasma drug concentration of enclitide decanoate to decrease by 50% from peak. Blood for plasma samples was collected at pre-specified time points to determine the t1/2 of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report t1/2. Per protocol, mean t1/2 was reported. | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
| Apparent Clearance (CL/F) of Enlicitide Decanoate | CL/F was the apparent total clearance of enlicitide decanoate in plasma over time. Blood for plasma samples was collected at pre-specified timepoints to determine the CL/F of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report CL/F. Per protocol, mean CL/F was reported. | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
| Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate | Vz/F was the apparent volume of distribution of enlicitide decanoate between the plasma and the rest of the body, after dose, assessed as the total volume of enlicitide decanoate that would need to be uniformly distributed to achieve the desired plasma drug concentration. Blood for plasma samples was collected at pre-specified time points to determine the Vz/F of Enlicitide Decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Vz/F. Per protocol, mean Vz/F was reported. | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
| Panel C: Dialysate Concentration (Cd) of Enlicitide Decanoate | Cd was the measure of the concentration of enlicitide decanoate in dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean Cd. | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
| Panel C: Amount of Enlicitide Decanoate Excreted (AEd) in Dialysate | AEd was the measure of the amount of enlicitide decanoate excreted in the dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean AEd. | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
| Panel C: Percentage of Dose (%Dose) of Enlicitide Decanoate Excreted in Dialysate | %Dose was the percentage of the dose of enlicitide decanoate excreted in the dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine %Dose. | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
| Amount of Enlicitide Decanoate Excreted in Urine From 0 to 24 Hours (AE0-24) After Administration of Enlicitide Decanoate | AE0-24 was the measure of the amount of enlicitide decanoate excreted at 0 to 24 hours. Urine samples were to be collected to determine the AE0-24 after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report AE0-24. Per protocol, mean AE0-24 was reported. | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours postdose |
| Percentage of Unchanged Enlicitide Decanoate Excreted in Urine (Fe) | Fe was the measure of the percentage of unchanged enlicitide decanoate excreted in the urine. The percentage of enlicitide decanoate that was excreted unchanged in urine over the 24-hr collection interval (Fe) was calculated as 100 times the ratio of Ae0-24 and dose. Urine samples were to be collected to determine the Fe after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Fe. | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
| Renal Clearance (CLr) of Enlicitide Decanoate | CLr was the measure of how quickly enlicitide decanoate was removed from the plasma by the kidney and excreted in urine. Urine samples were to be collected to determine the CLr after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report CLr. Per protocol, mean CLr was reported. | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported. | Up to approximately 30 days |
| Panels A, B, and D: Number of Participants Who Discontinued From the Study Due to an AE | An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of Panel A, B, and D participants who discontinued study treatment due to an AE were reported. | Up to approximately 30 days |
| Panel C: Number of Participants Who Discontinued From the Study Treatment Due to an AE | An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of Panel C participants who discontinued study treatment due to an AE were reported. | Up to approximately 30 days |
| Clinical Pharmacology of Miami ( Site 0005) |
| Miami |
| Florida |
| 33014-3616 |
| United States |
| Advanced Pharma CR, LLC ( Site 0001) | Miami | Florida | 33147 | United States |
| Orlando Clinical Research Center ( Site 0004) | Orlando | Florida | 32809 | United States |
| Genesis Clinical Research, LLC ( Site 0002) | Tampa | Florida | 33603 | United States |
| BG002 | Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD) | Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16. |
| BG003 | Panel D: Healthy Controls | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| OG001 | Panel B: Severe RI | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| OG002 | Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis | Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1. |
| OG003 | Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis | Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16. |
| OG004 | Panel D: Healthy Controls | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
|
|
|
| Primary | AUC From Time 0 to Last Measurable Concentration (AUClast) of Enlicitide Decanoate | AUClast was defined as the area under the concentration-time curve of enlicitide decanoate from time zero to last measurable concentration. Blood for plasma samples was collected at pre-specified timepoints to determine the AUClast of enlicitide decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUClast. Per protocol, mean AUClast was reported. | All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for AUClast. | Posted | Geometric Mean | 95% Confidence Interval | hr*nmol/Liter | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
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| Primary | Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate | Cmax was defined as the maximum or peak concentration of enlicitide decanoate observed after its administration. Blood for plasma samples was collected at pre-specified time points to determine the Cmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Cmax. Per protocol, mean Cmax was reported. | All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for Cmax. | Posted | Geometric Mean | 95% Confidence Interval | nmol/Liter | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate | Tmax was defined as the time required for a study drug to reach maximum concentration in plasma. Blood for plasma samples was collected at pre-specified time points to determine the Tmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Tmax. Per protocol, mean Tmax was reported. | All participants of Panel A, B, C and D who received at least a dose of study treatment and had data available for Tmax. | Posted | Median | Full Range | hours | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
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| Primary | Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate | Half-life (t1/2) was defined as the time required for plasma drug concentration of enclitide decanoate to decrease by 50% from peak. Blood for plasma samples was collected at pre-specified time points to determine the t1/2 of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report t1/2. Per protocol, mean t1/2 was reported. | All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for the t1/2. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
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| Primary | Apparent Clearance (CL/F) of Enlicitide Decanoate | CL/F was the apparent total clearance of enlicitide decanoate in plasma over time. Blood for plasma samples was collected at pre-specified timepoints to determine the CL/F of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report CL/F. Per protocol, mean CL/F was reported. | All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for the CL/F. | Posted | Geometric Mean | 95% Confidence Interval | Liter/hr | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
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| Primary | Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate | Vz/F was the apparent volume of distribution of enlicitide decanoate between the plasma and the rest of the body, after dose, assessed as the total volume of enlicitide decanoate that would need to be uniformly distributed to achieve the desired plasma drug concentration. Blood for plasma samples was collected at pre-specified time points to determine the Vz/F of Enlicitide Decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Vz/F. Per protocol, mean Vz/F was reported. | All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for the Vz/F. | Posted | Geometric Mean | 95% Confidence Interval | Liter | Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose |
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| Secondary | Panel C: Dialysate Clearance (CLd) of Enlicitide Decanoate | CLd was the measure of the amount of enlicitide decanoate cleared from plasma via dialysis. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean CLd. | Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported. | Posted | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
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| Secondary | Panel C: Dialysate Concentration (Cd) of Enlicitide Decanoate | Cd was the measure of the concentration of enlicitide decanoate in dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean Cd. | Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported. | Posted | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
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| Secondary | Panel C: Amount of Enlicitide Decanoate Excreted (AEd) in Dialysate | AEd was the measure of the amount of enlicitide decanoate excreted in the dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean AEd. | Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported. | Posted | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
|
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| Secondary | Panel C: Percentage of Dose (%Dose) of Enlicitide Decanoate Excreted in Dialysate | %Dose was the percentage of the dose of enlicitide decanoate excreted in the dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine %Dose. | Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported. | Posted | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
|
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| Secondary | Amount of Enlicitide Decanoate Excreted in Urine From 0 to 24 Hours (AE0-24) After Administration of Enlicitide Decanoate | AE0-24 was the measure of the amount of enlicitide decanoate excreted at 0 to 24 hours. Urine samples were to be collected to determine the AE0-24 after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report AE0-24. Per protocol, mean AE0-24 was reported. | All participants from Panel A, B, C, and D who received a dose of study treatment and had data available for AE0-24 were to be analyzed. No urine samples were collected on Panel C participants; therefore, no data were reported for this group. | Posted | Geometric Mean | 95% Confidence Interval | mg | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours postdose |
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| Secondary | Percentage of Unchanged Enlicitide Decanoate Excreted in Urine (Fe) | Fe was the measure of the percentage of unchanged enlicitide decanoate excreted in the urine. The percentage of enlicitide decanoate that was excreted unchanged in urine over the 24-hr collection interval (Fe) was calculated as 100 times the ratio of Ae0-24 and dose. Urine samples were to be collected to determine the Fe after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Fe. | All participants from Panel A, B, C, and D who received a dose of study treatment and had data available for Fe were to be analyzed. No urine samples were collected on Panel C participants; therefore, no data were reported for this group. | Posted | Geometric Mean | 95% Confidence Interval | Percentage of Enlicitide Decanoate | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
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| Secondary | Renal Clearance (CLr) of Enlicitide Decanoate | CLr was the measure of how quickly enlicitide decanoate was removed from the plasma by the kidney and excreted in urine. Urine samples were to be collected to determine the CLr after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report CLr. Per protocol, mean CLr was reported. | All participants from Panel A, B, C, and D who received a dose of study treatment and had data available for CLr were to be analyzed. No urine samples were collected on Panel C participants; therefore, no data were reported for this group. | Posted | Geometric Mean | 95% Confidence Interval | Liter/hr | Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
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| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported. | All allocated participants who received a dose of study treatment. Per protocol, AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms. | Posted | Count of Participants | Participants | Up to approximately 30 days |
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| Secondary | Panels A, B, and D: Number of Participants Who Discontinued From the Study Due to an AE | An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of Panel A, B, and D participants who discontinued study treatment due to an AE were reported. | All allocated participants in Panels A, B and D who received a dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 30 days |
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| Secondary | Panel C: Number of Participants Who Discontinued From the Study Treatment Due to an AE | An AE was 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of Panel C participants who discontinued study treatment due to an AE were reported. | All allocated participants in Panels C who received a dose of study treatment. Per protocol, AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms. | Posted | Count of Participants | Participants | Up to approximately 30 days |
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| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Panel B: Severe RI | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG002 | Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD) | Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16. | 0 | 9 | 1 | 9 | 0 | 9 |
| EG003 | Panel D: Healthy Controls | Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. | 0 | 8 | 0 | 8 | 0 | 8 |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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The sponsor must have the opportunity to review all manuscripts or abstracts before submission. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D009750 |
| Nutritional and Metabolic Diseases |
| Geometric Mean ratio |
| 0.79 |
| 2-Sided |
| 90 |
| 0.37 |
| 1.72 |
GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls |
| Other |
| Geometric Mean Ratio | 1.42 | 2-Sided | 90 | 0.80 | 2.54 | GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls | Other |
| Geometric Mean Ratio | 1.18 | 2-Sided | 90 | 0.78 | 1.78 | GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls | Other |
| Geometric Mean Ratio |
| 0.60 |
| 2-Sided |
| 90 |
| 0.34 |
| 1.04 |
GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls. |
| Other |
| Geometric Mean Ratio | 0.90 | 2-Sided | 90 | 0.64 | 1.27 | GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls. | Other |
| Geometric Mean Ratio | 1.18 | 2-Sided | 90 | 0.78 | 1.78 | GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls. | Other |
| Geometric Mean Ratio |
| 0.88 |
| 2-Sided |
| 90 |
| 0.58 |
| 1.35 |
GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls |
| Other |
| Geomtric Mean ratio | 0.57 | 2-Sided | 90 | 0.36 | 0.91 | GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls | Other |
| Geomtric Mean Ratio | 0.86 | 2-Sided | 90 | 0.57 | 1.29 | GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls | Other |
| Geometric Mean ratio |
| 1.08 |
| 2-Sided |
| 90 |
| 0.78 |
| 1.50 |
GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls |
| Other |
| Geometric Mean Ratio | 0.66 | 2-Sided | 90 | 0.50 | 0.89 | GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls | Other |
| Geometric Mean Ratio | 1.40 | 2-Sided | 90 | 1.00 | 1.97 | GMR and 90% CI for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls | Other |
| Geometric Mean Ratio |
| 0.09 |
| 2-Sided |
| 90 |
| 0.04 |
| 0.22 |
GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls |
| Other |
| Geometric Mean Ratio |
| 0.09 |
| 2-Sided |
| 90 |
| 0.04 |
| 0.22 |
GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls |
| Other |
| Geometric Mean Ratio |
| 0.14 |
| 2-Sided |
| 90 |
| 0.06 |
| 0.36 |
GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls |
| Other |