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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Velocity Clinical Research, New Smyrna Beach ( Site 0003)
Edgewater, Florida, United States
Advanced Pharma CR, LLC ( Site 0006)
Miami, Florida, United States
Genesis Clinical Research, LLC ( Site 0004)
Tampa, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0002)
Knoxville, Tennessee, United States
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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