A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) participants. The primary hypothesis is 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 is at least 1130 nM*hr.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MK-2060 MK-2060 administered as a single subcutaneous dose of 30 mg on Day 1 |
Biological: MK-2060
MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously
|
| Placebo Comparator: Placebo Placebo (normal saline) administered as a single subcutaneous dose on Day 1 |
Drug: Placebo
Normal saline administered subcutaneously
|
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 nonmajor 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 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.
- 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 will be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
- 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 will be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.
- 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 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 at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
- 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 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 [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 will be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
- 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 will be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
- 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 will be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma
Secondary Outcome Measures
- Percent Change from Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060 [Baseline and 90 days post-dose]
Blood will be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At the time of screening, has stage 4 chronic kidney disease.
-
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.
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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.
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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 the last 3 months.
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Has a history of or current frequent epistaxis within the last 3 months or active gingivitis.
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Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.
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Has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study.
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Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
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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.
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Has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Velocity Clinical Research, New Smyrna Beach ( Site 0003) | Edgewater | Florida | United States | 32132 |
| 2 | Genesis Clinical Research, LLC ( Site 0004) | Tampa | Florida | United States | 33603 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2060-011
- MK-2060-011