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Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)

An Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-3866 When Administered to Subjects With Moderate and Severe Hepatic Impairment

NCT03295266•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy participants. The primary purpose of this study is to understand the effect of HI on the plasma PK of MK-3866 in order to guide dosing recommendations for participants with HI. This study will also evaluate the safety and tolerability of MK-3866 in participants with moderate and severe HI.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Body mass index ≥19 \& ≤40 kg/m\^2
•Continuous non-smoker prior to screening \& enrollment
•HI Participants: Baseline health judged to be stable based on medical history (except for the HI condition), physical examination, vital signs, electrocardiograms, \& laboratory safety tests
•Healthy control participants: Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms
•HI Participants: Diagnosis of chronic (\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) HI with features of cirrhosis
•HI Participants - Panel A (moderate HI) only: score on the Child-Pugh scale from 7 to 9 (moderate HI). At least 3 participants must have a score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, international normalized ratio, and/or bilirubin) on the Child-Pugh scale
•HI Participants - Panel B (severe HI) only: Score on the Child-Pugh scale from 10 to 15 (severe HI)
•Is completely informed of the unknown risks of pregnancy \& agrees not to become pregnant or father a child during time in study
•For a female of childbearing potential: is either sexually inactive (abstinent) for 14 days prior to dosing \& throughout the study or is using an acceptable birth control method
•Non-vasectomized male: Participants must agree to use a condom with spermicide or abstain from sexual intercourse from dosing until 90 days after dosing

Exclusion Criteria

•Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
•Has a history or presence of clinically significant medical or psychiatric condition or disease (other than HI - Panels A \& B) that might confound the results of the study or poses an additional risk to the participant. Remote history of cholecystectomy that is not an active issue may be included.
•Panels A \& B: Has a clinically significant history of cancer. Remote history with full cure or limited disease with complete resection (cure) may be included
•Has a history of drug/alcohol abuse within the past 6 months prior to dosing (Panels A \& B) or within the past 2 years prior to dosing (Panel C \[Healthy controls\])
•Panels A \& B: Consumes more than 3 glasses of alcoholic beverages (1 glass approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\]) per day, within 6 months of screening. Participants that consume 4 glasses of alcoholic beverages/day may be enrolled
•Panels A \& B: Consumes excessive amounts, defined as more than 6 servings (1 serving approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy-drinks, or other caffeinated beverages/day
•Panels A \& B: Has a history of a liver transplant
•Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
•Has moderate or severe renal insufficiency (estimated glomerular filtration rate of ≤60 mL/min/1.73 m2 for moderate HI or healthy control participants or ≤50 mL/min/1.73 m2 for severe HI participants)
•Panel C: Has positive macroscopic urine protein at screening (trace protein by dipstick allowed)
+6 more criteria

Locations (2)

Clinical Pharmacology of Miami ( Site 0001)

Hialeah, Florida, United States

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, United States

Key Dates

Start Date

December 19, 2017

Primary Completion Date

March 15, 2018

Completion Date

March 15, 2018

Last Updated

November 13, 2019

Enrollment

ACTUAL participants

Conditions

Hepatic InsufficiencyAntibacterial Agents

Interventions

MK-3866

DRUG

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037

Hepatic InsufficiencyCirrhosis, Liver

View study

RECRUITING

Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa

NCT06738771

Pseudomonas InfectionsPseudomonas Aeruginosa+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)

Inclusion Criteria

Exclusion Criteria

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

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