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

NCT05769595 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 2060-012MK-2060-012jRCT2041230025
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 164 days

• Number of Participants Who Discontinued Study Due to an 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 discontinued study due to an AE is reported.

  Up to approximately 164 days

Secondary Outcomes (11)

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

  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

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

  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

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

  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

• Maximum Concentration (Cmax) of MK-2060

  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

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

  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

Study Arms (2)

MK-2060

EXPERIMENTAL

Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes.

Biological: MK-2060

Placebo

PLACEBO COMPARATOR

Participants receive a single IV saline infusion over 60 minutes.

Drug: Placebo

Interventions

MK-2060 BIOLOGICAL

Lyophilized powder diluted in normal saline for IV infusion

MK-2060

Placebo DRUG

IV infusion

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (12)

Kasugai Municipal Hospital ( Site 1203)

Kasugai, Aichi-ken, 486-8510, Japan

Location

Chubu Rosai Hospital ( Site 1202)

Nagoya, Aichi-ken, 455-8530, Japan

Location

Kojunkai Daido Hospital ( Site 1207)

Nagoya, Aichi-ken, 457-8511, Japan

Location

Jomo Ohashi Clinic ( Site 1210)

Maebashi, Gunma, 371-0046, Japan

Location

Ibaraki Prefectural Central Hospital ( Site 1211)

Kasama, Ibaraki, 309-1793, Japan

Location

Shonan Kamakura General Hospital ( Site 1205)

Kamakura, Kanagawa, 247-8533, Japan

Location

Matsumoto City Hospital ( Site 1209)

Matsumoto, Nagano, 390-1401, Japan

Location

Keiaikai Nakamura Hospital ( Site 1213)

Beppu, Oita Prefecture, 874-0937, Japan

Location

Omi Fureai Hospital ( Site 1204)

Kusatsu, Shiga, 525-8585, Japan

Location

Ikegami General Hospital ( Site 1206)

Ōta-ku, Tokyo, 146-8531, Japan

Location

Japanese Red Cross Fukuoka Hospital ( Site 1214)

Fukuoka, 815-8555, Japan

Location

Yamagata Tokushukai Hospital ( Site 1201)

Yamagata, 990-0834, Japan

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: June 14, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (12)