A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2060 in Japanese Older Participants With End-stage Renal Disease on Dialysis.
Overview
- Phase
- Phase 1
- Intervention
- MK-2060
- Conditions
- End-Stage Renal Disease (ESRD)
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 17
- Locations
- 12
- Primary Endpoint
- Number of Participants Who Experienced an Adverse Event (AE)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The main inclusion criteria include but are not limited to the following:
- •Japanese descent with all 2 biological parents of Japanese descent
- •On hemodialysis (HD) or hemodiafiltration (HDF) with single-pool Kt/V (spKt/V) ≥1.2, using arteriovenous (AV) fistula or AV graft ≥3 months prior to Screening 1 at a healthcare center, and is on the same dialysis regimen ≥2 weeks prior to Screening 1
- •Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit
Exclusion Criteria
- •The main exclusion criteria include but are not limited to the following:
- •On peritoneal dialysis or other dialysis modalities except for HD and HDF
- •History of deep vein thrombosis or pulmonary embolism
- •History of vascular access thrombosis within 1 month prior to Screening 1
- •Personal or family history of bleeding disorder
- •History of GI bleeding, duodenal polyps or active gastroduodenal ulcer within 5 years prior to Screening 1, or history of severe hemorrhoidal bleed within 3 months prior to Screening 1
- •History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis
- •At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial
- •History of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or a brand of Rho(D) immune globulin (RhoGAM) within 1 year prior to Screening 1
- •History of receiving any biological therapy within 3 months prior to Screening 1, or vaccination within 1 month prior to the dose of study intervention
Arms & Interventions
MK-2060
Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes.
Intervention: MK-2060
Placebo
Participants receive a single IV saline infusion over 60 minutes.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 164 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported.
Number of Participants Who Discontinued Study Due to an AE
Time Frame: Up to approximately 164 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported.
Secondary Outcomes
- Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Terminal Half-Life (t ½) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf)(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168)(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Time to Maximum Concentration (Tmax) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last)(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Maximum Concentration (Cmax) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Clearance (CL) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Volume of Distribution (Vz) of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Concentration at 168 Hours (C168) Postdose of MK-2060(Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis)
- Change From Baseline in Activated Partial Thromboplastin Time (aPTT)(Baseline and 168 hours post dose)