A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)

Part of paid clinical trials in Hallandale, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05070390
Phase
PHASE1
Status
Completed

Conditions

  • Moderate Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Enlicitide Chloride — DRUG
    10 mg capsule administered orally

Study Details

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 \<60milliliter/minute/1.73meters\^2 (ml/min/1.73m\^2). There is no formal hypothesis.

Key Dates

Start date
Nov 16, 2021
Status verified
Sep 2024
Primary completion
May 3, 2023
Completion
May 3, 2023

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Panel A - Moderate Renal Impairment (RI)
    Single dose of enlicitide chloride 10 mg
  • Experimental: Panel B - Healthy Controls
    Single dose of enlicitide chloride 10 mg

Primary Outcome Measure

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616 [ Time Frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose ]

Locations (2)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research, Hallandale Beach ( Site 0002)HallandaleFlorida33009-
Alliance for Multispecialty Research, LLC ( Site 0001)KnoxvilleTennessee37920-

Find similar trials in Hallandale, FL

By research site
Velocity Clinical Research, Hallandale Beach· Hallandale, FLAlliance for Multispecialty Research, LLC· Knoxville, TN

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