臨床研究等提出・公開システム

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.

Single Dose Study of MK-2060 in Japanese Older Participants on Dialysis

Tanaka Yoshiyuki

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Complete

June. 13, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Japanese descent with all 2 biological parents of Japanese descent
2) 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
3) Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit

1) On peritoneal dialysis or other dialysis modalities except for HD and HDF
2) History of deep vein thrombosis or pulmonary embolism
3) History of vascular access thrombosis within 1 month prior to Screening 1
4) Personal or family history of bleeding disorder
5) 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
6) History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis
7) At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial
8) 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
9) 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
10) Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs)
11) Participated in another investigational study within 1 month prior to Screening 1
12) 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

Both

end-stage renal disease

MK-2060 50 mg, Placebo

1) Number of Participants Who Experience an Adverse Event (AE)
2) Number of Participants Who Discontinue Study Due to an AE

1) Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf)
2) Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last)
3) Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168)
4) Maximum Concentration (Cmax) of MK-2060
5) Concentration at 168 Hours (C168) Postdose of MK-2060
6) Time to Maximum Concentration (Tmax) of MK-2060
7) Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060
8) Terminal Half-Life (t 1/2) of MK-2060
9) Clearance (CL) of MK-2060
10) Volume of Distribution (Vz) of MK-2060
11) Change From Baseline in Activated Partial Thromboplastin Time (aPTT)

+81-52-611-6261

Mar. 07, 2023

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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