A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
NCT ID: NCT06295796
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2024-06-20
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Moderate Renal Impairment
Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1.
MK-8527
Oral Capsule
Severe Renal Impairment
Participants with severe renal impairment receive a single dose of MK-8527 on Day 1.
MK-8527
Oral Capsule
Healthy
Healthy participants receive a single dose of MK-8527 on Day 1.
MK-8527
Oral Capsule
Interventions
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MK-8527
Oral Capsule
Eligibility Criteria
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Inclusion Criteria
* With the exception of RI, is in sufficient health for study participation.
* Has stable renal function.
Healthy
* Matches mean age to participants with moderate and severe RI.
* Has normal renal function.
Exclusion Criteria
* History of cancer (malignancy).
* Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
* Had a major surgery or lost significant volume of blood within 56 days prior to dosing.
* Donated plasma within 7 days prior to dosing.
Moderate and Severe RI
* Failed renal transplant or had a nephrectomy.
* End stage renal disease requiring dialysis.
* Any significant arrhythmia or conduction abnormality.
* Has non-sustained or sustained ventricular tachycardia.
18 Years
75 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Research by Design ( Site 0001)
Chicago, Illinois, United States
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8527-008
Identifier Type: OTHER
Identifier Source: secondary_id
8527-008
Identifier Type: -
Identifier Source: org_study_id
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