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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
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.
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.
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States
Prism Research ( Site 0003)
Saint Paul, Minnesota, United States
New Orleans Center for Clinical Research ( Site 0001)
Knoxville, Tennessee, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 118 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 weeks
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.
Time frame: 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)
Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 and Day 22
Part 2: C168 of MK-2060
Plasma samples were collected at 168 hours post-dose and C168 was assessed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Day 8