End-Stage Kidney Disease, End-Stage Renal Disease, Kidney Failure, Chronic
Conditions
Brief summary
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.
Interventions
BIOLOGICALMK-2060
MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously
DRUGPlacebo
Normal saline administered subcutaneously
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) or end-state kidney disease on peritoneal dialysis (Part 3). * Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m\^2.
Exclusion criteria
* Has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up. * Has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder. * Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in the last 3 months. * Has a history of or current frequent epistaxis within the last 3 months or active gingivitis. * Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted. * Has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study. * Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV). * Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study visit. * Has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year. * Has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or COVID-19 vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 3: Vz/F of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma |
| Part 3: CL/F of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. |
| Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060 | 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 | Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma |
| Part 2: Vz/F of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma |
| Part 3: t1/2 of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. |
| Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE) | Up to approximately 104 days | 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 2: Number of Participants Who Experience One or More Bleeding Related AEs | Up to approximately 144 days | 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 3: Number of Participants Who Experience One or More Bleeding Related AEs | Up to approximately 104 days | 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 1: Apparent Total Clearance (CL/F) of MK-2060 | 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 | Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. |
| Part 1: Number of Participants Who Experience One or More AEs | Up to approximately 104 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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: Number of Participants Who Experience One or More AEs | Up to approximately 144 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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: Number of Participants Who Experience One or More AEs | Up to approximately 104 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 1: Number of Participants Who Discontinue Study Treatment to an AE | Up to approximately 104 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 144 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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: Number of Participants Who Discontinue Study Due to an AE | Up to approximately 104 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060 | 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 | Blood was collected to determine the AUC0-inf of MK-2060 in plasma. |
| Part 2: AUC0-inf of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma. |
| Part 3: AUC0-inf of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma. |
| Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060 | Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose | Blood was collected to determine the AUC0-168 of MK-2060 in plasma. |
| Part 2: AUC0-168 of MK-2060 | Pre-dose, 24, 72, and 168 hours post-dose | 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: AUC0-168 of MK-2060 | Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose | 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 1: Maximum Plasma Concentration (Cmax) of MK-2060 | 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 | Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. |
| Part 2: Cmax of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. |
| Part 3: Cmax of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma. |
| Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060 | 168 hours post-dose | Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. |
| Part 2: C168 of MK-2060 | 168 hours post-dose | Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. |
| Part 3: C168 of MK-2060 | 168 hours post-dose | Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma. |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060 | 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 | Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. |
| Part 2: Tmax of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. |
| Part 3: Tmax of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma. |
| Part 1: Terminal Half Life (t1/2) of MK-2060 | 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 | Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. |
| Part 2: t1/2 of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma. |
| Part 2: CL/F of MK-2060 | 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 | Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Percent Change From Baseline in aPTT of MK-2060 | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) | Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. |
| Part 3: Percent Change From Baseline in aPTT of MK-2060 | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) | Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. |
| Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90) | 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. |
Countries
United States
Participant flow
Recruitment details
Adult participants with stage 4 chronic kidney disease (CKD4) were recruited.
Participants by arm
| Arm | Count |
|---|---|
| MK-2060 30 mg Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. | 11 |
| Placebo Participants receive placebo (normal saline) administered as a single subcutaneous dose on Day 1. | 3 |
| Total | 14 |
Baseline characteristics
| Characteristic | Placebo | Total | MK-2060 30 mg |
|---|---|---|---|
| Age, Continuous | 59.0 Years STANDARD_DEVIATION 17.4 | 68.5 Years STANDARD_DEVIATION 11.9 | 71.1 Years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 12 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 3 |
| other Total, other adverse events | 5 / 11 | 2 / 3 |
| serious Total, serious adverse events | 2 / 11 | 0 / 3 |
Outcome results
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.
Time frame: 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
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-2060 30 mg | Part 1: Apparent Total Clearance (CL/F) of MK-2060 | 0.0141 Liters/hour | Geometric Coefficient of Variation 40.9 |
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
Time frame: 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
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-2060 30 mg | Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060 | 13.8 Liters | Geometric Coefficient of Variation 39.6 |
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.
Time frame: 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
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-2060 30 mg | Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060 | 14300 hr*nM | Geometric Coefficient of Variation 40.9 |
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.
Time frame: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-2060 30 mg | Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060 | 727 hr*nM | Geometric Coefficient of Variation 103.3 |
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.
Time frame: 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
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-2060 30 mg | Part 1: Maximum Plasma Concentration (Cmax) of MK-2060 | 11.3 nM | Geometric Coefficient of Variation 38.8 |
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.
Time frame: Up to approximately 104 days
Population: All treated participants in Part 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MK-2060 30 mg | Part 1: Number of Participants Who Discontinue Study Treatment to an AE | 0 Participants |
| Placebo | Part 1: Number of Participants Who Discontinue Study Treatment to an AE | 0 Participants |
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.
Time frame: Up to approximately 104 days
Population: All treated participants in Part 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MK-2060 30 mg | Part 1: Number of Participants Who Experience One or More AEs | 5 Participants |
| Placebo | Part 1: Number of Participants Who Experience One or More AEs | 2 Participants |
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.
Time frame: Up to approximately 104 days
Population: All treated participants in Part 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MK-2060 30 mg | Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE) | 0 Participants |
| Placebo | Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE) | 0 Participants |
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.
Time frame: 168 hours post-dose
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-2060 30 mg | Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060 | 7.19 nM | Geometric Coefficient of Variation 79.7 |
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.
Time frame: 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
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-2060 30 mg | Part 1: Terminal Half Life (t1/2) of MK-2060 | 677 hours | Geometric Coefficient of Variation 26.3 |
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.
Time frame: 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
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MK-2060 30 mg | Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060 | 312.82 hours |
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.
Time frame: Pre-dose, 24, 72, and 168 hours post-dose
Population: Part 2 was never initiated.
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.
Time frame: 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
Population: Part 2 was never initiated.
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.
Time frame: 168 hours post-dose
Population: Part 2 was never initiated.
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.
Time frame: 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
Population: Part 2 was never initiated.
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.
Time frame: 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
Population: Part 2 was never initiated.
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.
Time frame: Up to approximately 144 days
Population: Part 2 was never initiated.
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.
Time frame: Up to approximately 144 days
Population: Part 2 was never initiated.
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.
Time frame: Up to approximately 144 days
Population: Part 2 was never initiated.
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.
Time frame: 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
Population: Part 2 was never initiated.
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.
Time frame: 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
Population: Part 2 was never initiated.
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
Time frame: 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
Population: Part 2 was never initiated.
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.
Time frame: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose
Population: Part 3 was never initiated.
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.
Time frame: 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
Population: Part 3 was never initiated.
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.
Time frame: 168 hours post-dose
Population: Part 3 was never initiated.
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.
Time frame: 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
Population: Part 3 was never initiated.
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.
Time frame: 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
Population: Part 3 was never initiated.
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.
Time frame: Up to approximately 104 days
Population: Part 3 was never initiated.
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.
Time frame: Up to approximately 104 days
Population: Part 3 was never initiated.
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.
Time frame: Up to approximately 104 days
Population: Part 3 was never initiated.
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.
Time frame: 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
Population: Part 3 was never initiated.
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.
Time frame: 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
Population: Part 3 was never initiated.
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
Time frame: 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
Population: Part 3 was never initiated.
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.
Time frame: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Population: All Part 1 participants treated with MK-2060 and who have data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 1: 1 Hour Postdose | 1.047 Mean fold change from baseline | Standard Error 0.028 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 1: 12 Hours Postdose | 1.044 Mean fold change from baseline | Standard Error 0.03 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 2 | 1.05 Mean fold change from baseline | Standard Error 0.021 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 3 | 1.137 Mean fold change from baseline | Standard Error 0.04 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 6 | 1.219 Mean fold change from baseline | Standard Error 0.059 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 8 | 1.202 Mean fold change from baseline | Standard Error 0.059 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 11 | 1.157 Mean fold change from baseline | Standard Error 0.063 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 14 | 1.128 Mean fold change from baseline | Standard Error 0.042 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 21 | 1.114 Mean fold change from baseline | Standard Error 0.037 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 28 | 1.07 Mean fold change from baseline | Standard Error 0.048 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 60 | 1.101 Mean fold change from baseline | Standard Error 0.038 |
| MK-2060 30 mg | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Post Study (Day 90) | 1.026 Mean fold change from baseline | Standard Error 0.044 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 60 | 1.053 Mean fold change from baseline | Standard Error 0.115 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 1: 1 Hour Postdose | 0.977 Mean fold change from baseline | Standard Error 0.037 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 11 | 1.08 Mean fold change from baseline | Standard Error 0.084 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 1: 12 Hours Postdose | 0.994 Mean fold change from baseline | Standard Error 0.017 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 28 | 1.012 Mean fold change from baseline | Standard Error 0.049 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 2 | 0.971 Mean fold change from baseline | Standard Error 0.02 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 14 | 1.102 Mean fold change from baseline | Standard Error 0.114 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 3 | 1.032 Mean fold change from baseline | Standard Error 0.033 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Post Study (Day 90) | 1.129 Mean fold change from baseline | Standard Error 0.064 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 6 | 1.075 Mean fold change from baseline | Standard Error 0.081 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 21 | 1.01 Mean fold change from baseline | Standard Error 0.075 |
| Placebo | Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 | Day 8 | 1.08 Mean fold change from baseline | Standard Error 0.093 |
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.
Time frame: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Population: Part 2 was never initiated.
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.
Time frame: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Population: Part 3 was never initiated.