Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacod… (NCT05769595) | Clinical Trial Compass
CompletedPhase 1
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
Japan17 participantsStarted 2023-06-14
Plain-language 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.
Who can participate
Age range50 Years – 80 Years
SexALL
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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 …
What they're measuring
1
Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to approximately 164 days
2
Number of Participants Who Discontinued Study Due to an AE