A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011)

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) participants. The primary hypothesis is that the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 participants is at least 1130 nM*hr.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

Criteria

Inclusion Criteria:

• At the time of screening, has stage 4 chronic kidney disease.

• Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m^2.

Exclusion Criteria:

• Has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up.

• Has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder.

• Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in the last 3 months.

• Has a history of or current frequent epistaxis within the last 3 months or active gingivitis.

• Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.

• Has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study.

• Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).

• Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study visit.

• Has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.

• Has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or COVID-19 vaccine.