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

Merck Sharp & Dohme LLC17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

End-Stage Renal Disease (ESRD)End-Stage Kidney Disease (ESKD)Kidney Failure, Chronic

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 * 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 * 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

Locations (12)

Kasugai Municipal Hospital ( Site 1203)

Kasugai, Aichi-ken, Japan

Chubu Rosai Hospital ( Site 1202)

Nagoya, Aichi-ken, Japan

Kojunkai Daido Hospital ( Site 1207)

Nagoya, Aichi-ken, Japan

Jomo Ohashi Clinic ( Site 1210)

Maebashi, Gunma, Japan

Ibaraki Prefectural Central Hospital ( Site 1211)

Kasama, Ibaraki, Japan

Shonan Kamakura General Hospital ( Site 1205)

Kamakura, Kanagawa, Japan

Matsumoto City Hospital ( Site 1209)

Matsumoto, Nagano, Japan

Keiaikai Nakamura Hospital ( Site 1213)

Beppu, Oita Prefecture, Japan

Omi Fureai Hospital ( Site 1204)

Kusatsu, Shiga, Japan

Ikegami General Hospital ( Site 1206)

Ōta-ku, Tokyo, Japan

...and 2 more locations

Outcomes

Primary Outcomes

Number of Participants Who Experienced an Adverse Event (AE)

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.

Time frame: Up to approximately 164 days

Number of Participants Who Discontinued Study Due to an AE

Time frame: Up to approximately 164 days

Secondary Outcomes

Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf)

Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity.