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Completed
NCT05070390
A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)
Conditions: Moderate Renal Impairment
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 18
Sponsor: Merck Sharp & Dohme LLC
Location: Velocity Clinical Research, Hallandale Beach ( Site 0002) Hallandale Florida
Summary
This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants. Moderate RI was defined as the estimated glomerular filtration rate (eGFR) ≥30 and \
Eligibility Criteria
Inclusion Criteria:
* Good health based upon medical history, physical examination, vital signs, laboratory safety tests, and electrocardiograms (ECG) performed before randomization
* Body mass index (BMI) ≥18 kg/m\^2 and ≤40 kg/m\^2
* Male participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm, PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent, or use acceptable contraception per study protocol
* Female participants must be of non-childbearing potential
* Moderate RI participants: Baseline estimated glomerular filtration rate (eGFR) ≥30 and \
Source: ClinicalTrials.gov (NCT05070390). StuddyBuddy aggregates publicly available trial information.