MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MK-2060 MK-2060 administered via intravenous (IV) infusion on days 1, 3, and 5 during the first week and on day 8 during the second week. |
Drug: MK-2060
MK-2060 administered via IV infusion
|
Outcome Measures
Primary Outcome Measures
- 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 non major bleeding or major bleeding.
- 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.
- Number of Participants who Discontinue Study Intervention Due to an AE [Up to approximately 8 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.
Secondary Outcome Measures
- Area Under the Concentration-Time Curve from 0 to 168 Hours (AUC0-168) of MK-2060 [At protocol specific time points predose and up to 168 hours post-dose]
Blood will be collected at pre-specified time points to determine the AUC of MK-2060 in plasma from 0 to 168 hours.
- Maximum plasma concentration (Cmax) of MK-2060 [At protocol specific time points up to 104 days]
Blood will be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma
- Plasma concentration at 168 Hours (C168) of MK-2060 [168 hours post-dose]
Blood will be collected 168 hours post-dose to determine the plasma concentration of MK-2060
- Time to Maximum Plasma Concentration (Tmax) of MK-2060 [At protocol specific time points up to 104 days]
Blood will be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma
- Terminal Half Life (t1/2) of MK-2060 [At protocol specific time points up to 104 days]
Blood will be collected at pre-specified time points to determine the t1/2 of MK-2060 in plasma
- Clearance (CL) of MK-2060 [At protocol specific time points up to 104 days]
Blood will be collected at pre-specified time points to determine the CL of MK-2060 in plasma
- Volume of Distribution (Vz) of MK-2060 [At protocol specific time points up to 104 days]
Blood will be collected at pre-specified time points to determine the Vz of MK-2060 in plasma
- Time to Hemostasis Following MK-2060 Treatment [Up to approximately 15 days]
Time to hemostasis is assessed by measuring the time that pressure is held from removal of dialysis catheters from the dialysis access site [i.e., arteriovenous (AV) fistula or AV graft] until adequate hemostasis has been obtained for both the arterial and venous sites.
Eligibility Criteria
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.
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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.
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Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.
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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.
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Has a history of deep vein thrombosis or pulmonary embolism.
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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.
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Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
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Has ongoing anticoagulant therapy or antiplatelet therapy, not including clopidogrel. Intradialytic heparin is permitted.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genesis Clinical Research ( Site 0003) | Tampa | Florida | United States | 33603 |
| 2 | Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002) | Jerusalem | Israel | 9112001 | |
| 3 | ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001) | București | Bucuresti | Romania | 010701 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharpe & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2060-008
- MK-2060-008
- 2021-005333-17