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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2060-004 | Other Identifier | Merck |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple doses in older adult participants with end-stage renal disease (ESRD) on hemodialysis (HD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Panel A- MK-2060 (8 mg) | Experimental | Participants will receive a single 8-mg dose of MK-2060 via intravenous (IV) infusion. |
|
| Part 1: Panel B- MK-2060 (20 mg) | Experimental | Participants will receive a single 20-mg dose of MK-2060 via IV infusion. |
|
| Part 1: Panel C- MK-2060 (40 mg) | Experimental | Participants will receive a single 40-mg dose of MK-2060 via IV infusion. |
|
| Part 1: Placebo | Placebo Comparator | Participants will receive a single dose of placebo via IV infusion. |
|
| Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance | Experimental | Participants will receive three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4) |
|
| Part 2: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2060 | Drug | Part 1: Single doses (8 mg, 20 mg, or 40 mg) of MK-2060 will be administered via IV infusion on Day 1. Part 2: Three doses of 25 mg of MK- 2060 administered via IV infusion on Days 1, 3 and 5; Followed by single doses of 25 mg of MK-2060 administered via IV infusion on Days 8, 15, and 22. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants With Any Adverse Event (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. The percentage of participants that experienced an AE was summarized. | Up to 164 days |
| Part 2: Percentage of Participants With Any 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. The percentage of participants who experienced an AE was summarized. | Up to 118 days |
| Part 1: Percentage of Participants With Any Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized. | Up to 164 days |
| Part 2: Percentage of Participants With Any SAE | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From 0 to Infinity (AUC0-inf) | Plasma samples were collected at pre-specified time points post-dose and AUC0-inf was assessed. | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150 |
| Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168) |
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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 |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center ( Site 0002) | Orlando | Florida | 32809 | United States | ||
| Prism Research ( Site 0003) |
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Male and Female of non-childbearing potential (WONCBP) participants with end-stage renal disease (ESRD) on hemodialysis (HD) between the ages of 18 and 80 years (ages ≥ 40 and ≤ 80 for Part 1 and ≥ 18 and ≤ 80 for Part 2) were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Panel A- MK-2060 (8 mg) | Participants received a single 8-mg dose of MK-2060 via intravenous (IV) infusion |
| FG001 | Part 1: Panel B- MK-2060 (20 mg) | Participants received a single 20-mg dose of MK-2060 via IV infusion |
| FG002 | Part 1: Panel C- MK-2060 (40 mg) | Participants received a single 40-mg dose of MK-2060 via IV infusion |
| FG003 | Part 1: Placebo | Participants received a single dose of placebo via IV infusion |
| FG004 | Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance | Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4) |
| FG005 | Part 2: Placebo | Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
| |||||||||||||
| Part 2 |
|
Seven participants in Part 1 also participated in Part 2. They have been removed from Part 2 listing and counted only once
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Panel A- MK-2060 (8 mg) | Participants received a single 8-mg dose of MK-2060 via IV infusion |
| BG001 | Part 1: Panel B- MK-2060 (20 mg) | Participants received a single 20-mg dose of MK-2060 via IV infusion |
| 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: Percentage of Participants With Any Adverse Event (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. The percentage of participants that experienced an AE was summarized. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 164 days |
|
Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of 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 | Part 1: Panel A- MK-2060 (8 mg) | Participants received a single 8-mg dose of MK-2060 via intravenous (IV) infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| 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 2, 2021 | Feb 21, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
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| Placebo Comparator |
Participants will receive three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4) |
|
|
| Placebo | Drug | Part 1: Single dose of placebo will be administered via IV infusion on Day 1. Part 2: Three doses of placebo administered via IV infusion on Days 1, 3 and 5; Followed by single doses of placebo administered via IV infusion on Days 8, 15, and 22. |
|
| Up to 118 days |
| Part 1: Percentage of Participants With a Systemic 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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath. | Up to 164 days |
| Part 2: Percentage of Participants With a Systemic 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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath. | Up to 118 days |
| Part 1: Percentage of Participants With an Injection-Site 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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling. | Up to 164 days |
| Part 2: Percentage of Participants With an Injection-Site 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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling. | Up to 118 days |
| Part 1: Percentage of Participants Discontinuing the 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. The percentage of participants that discontinued the study due to an AE was summarized. | Up to 164 days |
| Part 2: Percentage of Participants Discontinuing Study Drug 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. The percentage of participants that had study drug discontinued regardless of study completion status was summarized. | Up to 4 weeks |
Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed. |
| Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed. | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150 |
| Part 1: Plasma Concentration of MK-2060 at 168 Hours (C168) | Plasma samples were collected at 168 hours post-dose and C168 was assessed. | 168 hours post dose |
| Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed. | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
| Part 1: Plasma Elimination Terminal Half-life (t ½) of MK-2060 | Plasma samples was collected at pre-specified time points post-dose and t ½ was assessed. | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
| Part 1: Plasma Clearance (CL) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and CL was assessed. | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
| Part 1: Plasma Volume of Distribution (Vz) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Vz was assessed. | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
| Part 2: AUC0-168 of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed. | Up to 168 hours on Day 1 and Day 22 |
| Part 2: Cmax of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed. | Day 1 and Day 22 |
| Part 2: C168 of MK-2060 | Plasma samples were collected at 168 hours post-dose and C168 was assessed. | 168 hours post dose on Days 1 and 22 |
| Part 2: Tmax of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed. | Day 1 and Day 22 |
| Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060: Part 1 | Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported. | Baseline and 168 hours post-dose (Day 8) |
| Fold Change From Baseline in aPTT of MK-2060: Part 2 | Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported. | Baseline and Day 8 |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| New Orleans Center for Clinical Research ( Site 0001) | Knoxville | Tennessee | 37920 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Part 1: Panel C- MK-2060 (40 mg) | Participants received a single 40-mg dose of MK-2060 via IV infusion |
| BG003 | Part 1: Placebo | Participants received a single dose of placebo via IV infusion |
| BG004 | Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance | Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4) |
| BG005 | Part 2: Placebo | Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4) |
| BG006 | 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 |
|
| OG001 |
| Part 1: Panel B- MK-2060 (20 mg) |
Participants received a single 20-mg dose of MK-2060 via IV infusion |
| OG002 | Part 1: Panel A- MK-2060 (40 mg) | Participants received a single 40-mg dose of MK-2060 via IV infusion |
| OG003 | Part 1: Placebo | Participants received a single dose of placebo via IV infusion |
|
|
| Primary | Part 2: Percentage of Participants With Any 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. The percentage of participants who experienced an AE was summarized. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 118 days |
|
|
|
| Primary | Part 1: Percentage of Participants With Any Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 164 days |
|
|
|
| Primary | Part 2: Percentage of Participants With Any SAE | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 118 days |
|
|
|
| Primary | Part 1: Percentage of Participants With a Systemic 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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 164 days |
|
|
|
| Primary | Part 2: Percentage of Participants With a Systemic 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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 118 days |
|
|
|
| Primary | Part 1: Percentage of Participants With an Injection-Site 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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 164 days |
|
|
|
| Primary | Part 2: Percentage of Participants With an Injection-Site 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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 118 days |
|
|
|
| Primary | Part 1: Percentage of Participants Discontinuing the 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. The percentage of participants that discontinued the study due to an AE was summarized. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 164 days |
|
|
|
| Primary | Part 2: Percentage of Participants Discontinuing Study Drug 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. The percentage of participants that had study drug discontinued regardless of study completion status was summarized. | All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment. | Posted | Number | Percentage of Participants | Up to 4 weeks |
|
|
|
| Secondary | Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From 0 to Infinity (AUC0-inf) | Plasma samples were collected at pre-specified time points post-dose and AUC0-inf was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nmol/Liter | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150 |
|
|
|
|
| Secondary | Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168) | Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nmol/Liter | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
|
|
|
|
| Secondary | Part 1: Maximum Observed Plasma Concentration (Cmax) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/Liter | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150 |
|
|
|
|
| Secondary | Part 1: Plasma Concentration of MK-2060 at 168 Hours (C168) | Plasma samples were collected at 168 hours post-dose and C168 was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/Liter | 168 hours post dose |
|
|
|
|
| Secondary | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Median | Full Range | Hours | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
|
|
|
| Secondary | Part 1: Plasma Elimination Terminal Half-life (t ½) of MK-2060 | Plasma samples was collected at pre-specified time points post-dose and t ½ was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
|
|
|
| Secondary | Part 1: Plasma Clearance (CL) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and CL was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
|
|
|
| Secondary | Part 1: Plasma Volume of Distribution (Vz) of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Vz was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose |
|
|
|
| Secondary | Part 2: AUC0-168 of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nmol/L | Up to 168 hours on Day 1 and Day 22 |
|
|
|
| Secondary | Part 2: Cmax of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/Liter | Day 1 and Day 22 |
|
|
|
| Secondary | Part 2: C168 of MK-2060 | Plasma samples were collected at 168 hours post-dose and C168 was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/Liter | 168 hours post dose on Days 1 and 22 |
|
|
|
| Secondary | Part 2: Tmax of MK-2060 | Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Median | Full Range | Hours | Day 1 and Day 22 |
|
|
|
| Secondary | Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060: Part 1 | Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Number | 95% Confidence Interval | Ratio | Baseline and 168 hours post-dose (Day 8) |
|
|
|
| Secondary | Fold Change From Baseline in aPTT of MK-2060: Part 2 | Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported. | Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Number | 95% Confidence Interval | Ratio | Baseline and Day 8 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Part 1: Panel B- MK-2060 (20 mg) | Participants received a single 20-mg dose of MK-2060 via IV infusion | 0 | 7 | 0 | 7 | 4 | 7 |
| EG002 | Part 1: Panel C- MK-2060 (40 mg) | Participants received a single 40-mg dose of MK-2060 via IV infusion | 0 | 6 | 1 | 6 | 3 | 6 |
| EG003 | Part 1: Placebo | Participants received a single dose of placebo via IV infusion | 0 | 5 | 0 | 5 | 3 | 5 |
| EG004 | Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance | Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4) | 0 | 16 | 1 | 16 | 1 | 16 |
| EG005 | Part 2: Placebo | Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4) | 0 | 5 | 3 | 5 | 4 | 5 |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Occult blood positive | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
The results of this study may be published or presented at scientific meetings. The Sponsor will comply with the requirements for publication of study results. 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 |
| GMR |
| 0.53 |
| 2-Sided |
| 90 |
| 0.37 |
| 0.76 |
GMR=GM ESRD/GM Healthy |
| Other |
GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001). |
| GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001). | GMR | 0.82 | 2-Sided | 90 | 0.55 | 1.21 | GMR=GM ESRD/GM Healthy | Other |
| GMR |
| 0.86 |
| 2-Sided |
| 90 |
| 0.67 |
| 1.11 |
GMR=GM ESRD/GM Healthy |
| Other |
| GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001). | GMR | 0.82 | 2-Sided | 90 | 0.62 | 1.08 | GMR=GM ESRD/GM Healthy | Other |
| GMR |
| 0.68 |
| 2-Sided |
| 90 |
| 0.52 |
| 0.87 |
GMR=GM ESRD/GM Healthy |
| Other |
| GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001). | GMR | 0.78 | 2-Sided | 90 | 0.60 | 1.03 | GMR=GM ESRD/GM Healthy | Other |
| GMR |
| 0.91 |
| 2-Sided |
| 90 |
| 0.67 |
| 1.25 |
GMR=GM ESRD/GM Healthy |
| Other |
| GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001). | GMR | 0.86 | 2-Sided | 90 | 0.62 | 1.20 | GMR=GM ESRD/GM Healthy | Other |
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