Clinical trial NCT05335005: MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
Official title: A Study to Evaluate Safety and Tolerability of Co-administration of MK-2060 and Clopidogrel in Participants With End-Stage Renal Disease on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End-Stage Renal Disease
Kidney Failure, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MK-2060 is being developed for prevention of thrombotic complications in end-stage renal disease (ESRD). The purpose of this study is to conduct a preliminary evaluation of the safety and tolerability of MK-2060 treatment in combination with a commonly used P2Y12 receptor inhibitor, clopidogrel, in ESRD patients.


Eligibility criteria: Inclusion Criteria:

* Has End-Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen at a healthcare center for \> 3 months prior to dosing.
* On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft.
* Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.
* Has a Body Mass Index (BMI) ≥ 18 and ≤ 45 kg/m\^2.

Exclusion Criteria:

* History of cancer (malignancy), including adenocarcinoma, except adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up.
* Has a history of deep vein thrombosis or pulmonary embolism.
* Has a history of gastrointestinal (GI) bleeding, duodenal polyps or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in last 3 months prior to screening.
* Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
* Has ongoing anticoagulant therapy or antiplatelet therapy, not including clopidogrel. Intradialytic heparin is permitted.

Primary outcomes:
measure: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)
timeFrame: Up to approximately 104 days
measure: Number of Participants Who Experience One or More AEs
timeFrame: Up to approximately 104 days
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 8 days
Secondary outcomes:
measure: Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) of MK-2060
timeFrame: Day 1: predose, and 1, 12, 24, and 48 hours postdose. Day 8: predose, and 1, 12, 24, 48, 96, and 168 hours postdose.
measure: Maximum Plasma Concentration (Cmax) of MK-2060
timeFrame: Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
measure: Plasma Concentration at 168 Hours (C168) of MK-2060
timeFrame: Days 1 and 8: 168 hours post-dose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-2060
timeFrame: Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
measure: Terminal Half Life (t1/2) of MK-2060
timeFrame: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
measure: Clearance at Steady State (CLss) of MK-2060
timeFrame: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
measure: Apparent Volume of Distribution at Steady State (Vss) of MK-2060
timeFrame: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
measure: Time to Hemostasis Following MK-2060 Treatment
timeFrame: Up to approximately 15 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0003)
state: Florida
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)
city: București
country: Romania
facility: ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001)
state: Bucuresti
Study officials:
affiliation: Merck Sharpe & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: