Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

Korábbi kezelés

• History of vascular access thrombosis within 1 month prior to Screening 1
• 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
• Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs)
• Participated in another investigational study within 1 month prior to Screening 1

Más betegség

• History of deep vein thrombosis or pulmonary embolism
• Personal or family history of bleeding disorder

Laborértékek

• Has blood coagulation test (activated partial thromboplastin time [aPTT] or prothrombin time [PT]) above 1.2X upper limit of normal (ULN) at Screening 1 from the central laboratory for safety

Egyéb

• The main exclusion criteria include but are not limited to the following:
• On peritoneal dialysis or other dialysis modalities except for HD and HDF

• 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