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Completed

NCT Number: NCT05769595

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

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.

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Key information

Conditions

End-stage Renal Disease (ESRD) Chronic Disease Disease Attributes End-Stage Kidney Disease (ESKD) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kasugai Municipal Hospital ( Site 1203), Kasugai, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-2060

Biological

Lyophilized powder diluted in normal saline for IV infusion

Placebo

Drug

IV infusion

Other names: Normal saline

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: 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

    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.

  2. Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last)

    Time frame: 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

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

  3. Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168)

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of AUC0-168. AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours.

  4. Maximum Concentration (Cmax) of MK-2060

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-2060 reached.

  5. Concentration at 168 Hours (C168) Postdose of MK-2060

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of C168. C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose.

  6. Time to Maximum Concentration (Tmax) of MK-2060

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of Tmax. Tmax is defined as time to the maximum concentration of MK-2060 reached.

  7. Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of Tlast. Tlast is defined as the time to the last measurable concentration of MK-2060 reached.

  8. Terminal Half-Life (t ½) of MK-2060

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of t½. t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060.

  9. Clearance (CL) of MK-2060

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of CL. CL is the volume of plasma from which the study drug is completely removed per unit time.

  10. Volume of Distribution (Vz) of MK-2060

    Time frame: 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

    Blood samples were collected at specified intervals for the determination of Vz. Vz is the apparent volume of distribution during the terminal phase.

  11. Change From Baseline in Activated Partial Thromboplastin Time (aPTT)

    Time frame: Baseline and 168 hours post dose

    Blood samples were collected for the determination of aPTT. Change from baseline in aPTT up to 168 hours post dose (pre dialysis) is reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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