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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2060-011 | Other Identifier | MSD |
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This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety). The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) [Part2 was intended to evaluate multiple subcutaneous doses in CKD4 participants and Part 3 was intended to evaluate a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease (ESRD)]. The primary hypothesis for Part 1 was that the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 participants would be at least 11300 nM*hr.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-2060 30 mg | Experimental | Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. |
|
| Placebo | Placebo Comparator | Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2060 | Biological | MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE) | Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding. | Up to approximately 104 days |
| Part 2: Number of Participants Who Experience One or More Bleeding Related AEs | Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding. | Up to approximately 144 days |
| Part 3: Number of Participants Who Experience One or More Bleeding Related AEs | Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding. | Up to approximately 104 days |
| Part 1: Number of Participants Who Experience One or More AEs | 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. 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. | Up to approximately 104 days |
| Part 2: Number of Participants Who Experience One or More AEs | 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Blood was collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. Positive and negative scores indicate increases and decreases, respectively, in aPTT compared to baseline. | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) |
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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, New Smyrna Beach ( Site 0003) | Edgewater | Florida | 32132 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Adult participants with stage 4 chronic kidney disease (CKD4) were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-2060 30 mg | Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. |
| FG001 | Placebo | Participants receive placebo (normal saline) administered as a single subcutaneous dose on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-2060 30 mg | Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. |
| BG001 | Placebo | Participants receive placebo (normal saline) administered as a single subcutaneous dose 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 | Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE) | Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding. | All treated participants in Part 1 are included. | Posted | Count of Participants | Participants | Up to approximately 104 days |
|
Up to approximately 104 days
All treated participants are included.
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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 | MK-2060 30 mg | Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eustachian tube obstruction | Ear and labyrinth disorders | MedDRA 27.1 | 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 | Oct 31, 2023 | Aug 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Placebo | Drug | Normal saline administered subcutaneously |
|
| Up to approximately 144 days |
| Part 3: Number of Participants Who Experience One or More AEs | 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. 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. | Up to approximately 104 days |
| Part 1: Number of Participants Who Discontinue Study Treatment to an AE | 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. 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. | Up to approximately 104 days |
| Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE | 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. 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. | Up to approximately 144 days |
| Part 3: Number of Participants Who Discontinue Study Due to an AE | 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. 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. | Up to approximately 104 days |
| Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060 | Blood was collected to determine the AUC0-inf of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
| Part 2: AUC0-inf of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma. | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
| Part 3: AUC0-inf of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
| Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060 | Blood was collected to determine the AUC0-168 of MK-2060 in plasma. | Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose |
| Part 2: AUC0-168 of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours. | Pre-dose, 24, 72, and 168 hours post-dose |
| Part 3: AUC0-168 of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours. | Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose |
| Part 1: Maximum Plasma Concentration (Cmax) of MK-2060 | Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
| Part 2: Cmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
| Part 3: Cmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
| Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060 | Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. | 168 hours post-dose |
| Part 2: C168 of MK-2060 | Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. | 168 hours post-dose |
| Part 3: C168 of MK-2060 | Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. | 168 hours post-dose |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060 | Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
| Part 2: Tmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
| Part 3: Tmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
| Part 1: Terminal Half Life (t1/2) of MK-2060 | Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
| Part 2: t1/2 of MK-2060 | Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
| Part 3: t1/2 of MK-2060 | Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
| Part 1: Apparent Total Clearance (CL/F) of MK-2060 | Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
| Part 2: CL/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
| Part 3: CL/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
| Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060 | Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
| Part 2: Vz/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
| Part 3: Vz/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
| Part 2: Percent Change From Baseline in aPTT of MK-2060 | Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) |
| Part 3: Percent Change From Baseline in aPTT of MK-2060 | Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) |
| Advanced Pharma CR, LLC ( Site 0006) |
| Miami |
| Florida |
| 33147 |
| United States |
| Genesis Clinical Research, LLC ( Site 0004) | Tampa | Florida | 33603 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0002) | Knoxville | Tennessee | 37920 | United States |
| BG002 | 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 |
|
|
|
| Primary | Part 2: Number of Participants Who Experience One or More Bleeding Related AEs | Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding. | Part 2 was never initiated. | Posted | Up to approximately 144 days |
|
|
| Primary | Part 3: Number of Participants Who Experience One or More Bleeding Related AEs | Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding. | Part 3 was never initiated. | Posted | Up to approximately 104 days |
|
|
| Primary | Part 1: Number of Participants Who Experience One or More AEs | 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. 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. | All treated participants in Part 1 are included. | Posted | Count of Participants | Participants | Up to approximately 104 days |
|
|
|
| Primary | Part 2: Number of Participants Who Experience One or More AEs | 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. 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. | Part 2 was never initiated. | Posted | Up to approximately 144 days |
|
|
| Primary | Part 3: Number of Participants Who Experience One or More AEs | 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. 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. | Part 3 was never initiated. | Posted | Up to approximately 104 days |
|
|
| Primary | Part 1: Number of Participants Who Discontinue Study Treatment to an AE | 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. 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. | All treated participants in Part 1 are included. | Posted | Count of Participants | Participants | Up to approximately 104 days |
|
|
|
| Primary | Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE | 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. 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. | Part 2 was never initiated. | Posted | Up to approximately 144 days |
|
|
| Primary | Part 3: Number of Participants Who Discontinue Study Due to an AE | 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. 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. | Part 3 was never initiated. | Posted | Up to approximately 104 days |
|
|
| Primary | Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060 | Blood was collected to determine the AUC0-inf of MK-2060 in plasma. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
|
|
|
| Primary | Part 2: AUC0-inf of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma. | Part 2 was never initiated. | Posted | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
|
|
| Primary | Part 3: AUC0-inf of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma. | Part 3 was never initiated. | Posted | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
|
|
| Primary | Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060 | Blood was collected to determine the AUC0-168 of MK-2060 in plasma. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose |
|
|
|
| Primary | Part 2: AUC0-168 of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours. | Part 2 was never initiated. | Posted | Pre-dose, 24, 72, and 168 hours post-dose |
|
|
| Primary | Part 3: AUC0-168 of MK-2060 | Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours. | Part 3 was never initiated. | Posted | Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose |
|
|
| Primary | Part 1: Maximum Plasma Concentration (Cmax) of MK-2060 | Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
|
|
|
| Primary | Part 2: Cmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. | Part 2 was never initiated. | Posted | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
|
|
| Primary | Part 3: Cmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. | Part 3 was never initiated. | Posted | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
|
|
| Primary | Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060 | Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | 168 hours post-dose |
|
|
|
| Primary | Part 2: C168 of MK-2060 | Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. | Part 2 was never initiated. | Posted | 168 hours post-dose |
|
|
| Primary | Part 3: C168 of MK-2060 | Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. | Part 3 was never initiated. | Posted | 168 hours post-dose |
|
|
| Primary | Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060 | Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Median | Full Range | hours | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
|
|
|
| Primary | Part 2: Tmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. | Part 2 was never initiated. | Posted | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
|
|
| Primary | Part 3: Tmax of MK-2060 | Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. | Part 3 was never initiated. | Posted | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
|
|
| Primary | Part 1: Terminal Half Life (t1/2) of MK-2060 | Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
|
|
|
| Primary | Part 2: t1/2 of MK-2060 | Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. | Part 2 was never initiated. | Posted | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
|
|
| Primary | Part 3: t1/2 of MK-2060 | Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. | Part 3 was never initiated. | Posted | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
|
|
| Primary | Part 1: Apparent Total Clearance (CL/F) of MK-2060 | Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
|
|
|
| Primary | Part 2: CL/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. | Part 2 was never initiated. | Posted | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
|
|
| Primary | Part 3: CL/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. | Part 3 was never initiated. | Posted | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
|
|
| Primary | Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060 | Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose |
|
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| Primary | Part 2: Vz/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma | Part 2 was never initiated. | Posted | Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose |
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| Primary | Part 3: Vz/F of MK-2060 | Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma | Part 3 was never initiated. | Posted | Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose |
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| Secondary | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Blood was collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. Positive and negative scores indicate increases and decreases, respectively, in aPTT compared to baseline. | All Part 1 participants treated with MK-2060 and who have data available are included. | Posted | Mean | Standard Error | Mean fold change from baseline | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) |
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| Secondary | Part 2: Percent Change From Baseline in aPTT of MK-2060 | Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. | Part 2 was never initiated. | Posted | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) |
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| Secondary | Part 3: Percent Change From Baseline in aPTT of MK-2060 | Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. | Part 3 was never initiated. | Posted | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) |
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| 0 |
| 11 |
| 2 |
| 11 |
| 5 |
| 11 |
| EG001 | Placebo | Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1. | 0 | 3 | 0 | 3 | 2 | 3 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Occult blood positive | Investigations | MedDRA 27.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 1: 12 Hours Postdose |
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| Day 2 |
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| Day 3 |
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| Day 6 |
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| Day 8 |
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| Day 11 |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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| Day 60 |
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| Post Study (Day 90) |
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