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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-007 | Other Identifier | Merck |
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This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants. Moderate RI was defined as the estimated glomerular filtration rate (eGFR) ≥30 and <60milliliter/minute/1.73meters^2 (ml/min/1.73m^2). There is no formal hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Experimental | Single dose of enlicitide chloride 10 mg |
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| Panel B - Healthy Controls | Experimental | Single dose of enlicitide chloride 10 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide Chloride | Drug | 10 mg capsule administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-0616. AUC0-inf was defined as the area under the concentration-time curve of MK-0616 from time zero to infinity. | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
| Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616. | Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration. | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
| Maximum Plasma Concentration (Cmax) of MK-0616 | Blood samples were collected at pre-specified time points to determine the Cmax of MK-0616. Cmax was defined as the maximum concentration of MK-0616 reached. | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the Tmax of MK-0616. Tmax was defined as time to the maximum concentration of MK-0616 reached. | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
| Apparent Terminal Half-life (t1/2) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the t1/2 of MK-0616. t1/2 was defined as the time required to divide the MK-0616 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-0616. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. |
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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 0002) | Hallandale | Florida | 33009 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Of 24 participants screened for inclusion, 18 participants were allocated to receive MK-0616 single dose 10-mg. All participants received at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A - Moderate Renal Impairment (RI) | Participants with moderate RI received a single dose of MK-616 10mg orally on Day 1. |
| FG001 | Panel B - Healthy Controls | Healthy matched control participants received a single dose of MK-0616 10 mg orally on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All allocated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A - Moderate Renal Impairment (RI) | Participants with moderate RI received a single dose of MK-616 10mg orally on Day 1. |
| BG001 | Panel B - Healthy Controls | Healthy matched control participants received a single dose of MK-0616 10 mg orally on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| 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 MK-0616 | Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-0616. AUC0-inf was defined as the area under the concentration-time curve of MK-0616 from time zero to infinity. | All allocated participants who received a dose of study intervention and had data available for AUC0-inf. | Posted | Geometric Mean | 95% Confidence Interval | hour*nmol/Liter | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
|
Up to approximately 16 days
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received a dose of study treatment.
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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 RI | Participants with moderate renal impairment (RI) received a single dose of MK-616 10mg orally on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 26.0 | 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@merck.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 | Feb 22, 2023 | Apr 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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| Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
| Apparent Clearance (CL/F) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma. | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
| Apparent Volume of Distribution (Vz/F) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration. | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
| Up to approximately 14 days |
| 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 unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who discontinued from the study due to an AE were reported. | Up to approximately 14 days |
| Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616 | Urine samples were collected at pre-specified time points to determine the AE0-24 of MK-0616. Ae0-24 was defined as the amount of MK-0616 recovered in urine from time 0-24 hours. | Predose and at 0, 4, 8, 12 and 24 hours postdose |
| Fraction of Dose Recovered in Urine (Fe) of MK-0616 | Urine samples were collected at pre-specified time points to determine the Fe of MK-0616. Fe was defined as the fraction of dose of MK-0616 recovered in urine. | Predose and at 0, 4, 8, 12, 24, 36 and 48 hours postdose |
| Renal Clearance (CLr) of MK-0616 | Urine samples were collected at pre-specified time points to determine the CLr of MK-0616. was defined as the time it takes for the MK-0616 to be completely removed by the kidneys. | Predose and 4, 8, 12, 24, 36, and 48 hours postdose |
| Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Urine samples were collected at pre-specified time points (baseline and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 and 336 hours postdose) to evaluate the reduction in free PCSK9 from baseline to up to 336 hours postdose after administration of MK-0616. The percent change from baseline in free PCSK9 was reported. | Baseline (Predose) and up to 336 hours post dose |
| Alliance for Multispecialty Research, LLC ( Site 0001) |
| Knoxville |
| Tennessee |
| 37920 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Healthy matched control participants received a single dose of MK-0616 10 mg orally on Day 1. |
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| Primary | Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616. | Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration. | All allocated participants who received a dose of study intervention and had data available for AUC0-last. | Posted | Geometric Mean | 95% Confidence Interval | hour*nmol/Liter | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
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| Primary | Maximum Plasma Concentration (Cmax) of MK-0616 | Blood samples were collected at pre-specified time points to determine the Cmax of MK-0616. Cmax was defined as the maximum concentration of MK-0616 reached. | All allocated participants who received a dose of study intervention and had data available for Cmax. | Posted | Geometric Mean | 95% Confidence Interval | nmol/Liter | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the Tmax of MK-0616. Tmax was defined as time to the maximum concentration of MK-0616 reached. | All allocated participants who received a dose of study intervention and had data available for Tmax. | Posted | Median | Full Range | Hour | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
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| Primary | Apparent Terminal Half-life (t1/2) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the t1/2 of MK-0616. t1/2 was defined as the time required to divide the MK-0616 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-0616. | All allocated participants who received a dose of study intervention and had data available for t1/2. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
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| Primary | Apparent Clearance (CL/F) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma. | All allocated participants who received a dose of study intervention and had data available for CL/F. | Posted | Geometric Mean | 95% Confidence Interval | Liter/hour | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose |
|
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| Primary | Apparent Volume of Distribution (Vz/F) of MK-0616 | Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration. | All allocated participants who received a dose of study intervention and had data available for Vz/F. | Posted | Geometric Mean | 95% Confidence Interval | Liter | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 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 unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. | All allocated participants who received a dose of intervention. | Posted | Count of Participants | Participants | Up to approximately 14 days |
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| Secondary | 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 unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who discontinued from the study due to an AE were reported. | All allocated participants who received a dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 14 days |
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| Secondary | Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616 | Urine samples were collected at pre-specified time points to determine the AE0-24 of MK-0616. Ae0-24 was defined as the amount of MK-0616 recovered in urine from time 0-24 hours. | All allocated participants who received a dose of study intervention and had data available for Ae0-24. | Posted | Geometric Mean | 95% Confidence Interval | Miligram | Predose and at 0, 4, 8, 12 and 24 hours postdose |
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| Secondary | Fraction of Dose Recovered in Urine (Fe) of MK-0616 | Urine samples were collected at pre-specified time points to determine the Fe of MK-0616. Fe was defined as the fraction of dose of MK-0616 recovered in urine. | All allocated participants who received a dose of study intervention and had data available for Fe. | Posted | Geometric Mean | 95% Confidence Interval | Percent | Predose and at 0, 4, 8, 12, 24, 36 and 48 hours postdose |
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| Secondary | Renal Clearance (CLr) of MK-0616 | Urine samples were collected at pre-specified time points to determine the CLr of MK-0616. was defined as the time it takes for the MK-0616 to be completely removed by the kidneys. | All allocated participants who received a dose of study intervention and had data available for CLr. | Posted | Geometric Mean | 95% Confidence Interval | Liter/hour | Predose and 4, 8, 12, 24, 36, and 48 hours postdose |
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| Secondary | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Urine samples were collected at pre-specified time points (baseline and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 and 336 hours postdose) to evaluate the reduction in free PCSK9 from baseline to up to 336 hours postdose after administration of MK-0616. The percent change from baseline in free PCSK9 was reported. | All allocated participants who received a dose of study intervention, and had a baseline measure and at least one postbaseline measure of PCSK9. | Posted | Geometric Mean | 90% Confidence Interval | Percent Change | Baseline (Predose) and up to 336 hours post dose |
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| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Panel A - Moderate Renal Impairment (RI) | Participants with moderate RI received a single dose of MK-616 10mg orally on Day 1. | 0 | 8 | 0 | 8 | 2 | 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Axillary pain | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding thist rial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Change from baseline to 1.5 hours postdose |
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| Change from baseline to 2 hours postdose |
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| Change from baseline to 3 hours postdose |
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| Change from baseline to 5 hours postdose |
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| Change from baseline to 8 hours postdose |
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| Change from baseline to 12 hours postdose |
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| Change from baseline to 24 hours postdose |
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| Change from baseline to 36 hours postdose |
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| Change from baseline to 48 hours postdose |
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| Change from baseline to 336 hours postdose |
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