Status:
TERMINATED
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatic Insufficiency
Antibacterial Agents
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
- Is a female participant who is pregnant or lactating
- Has positive results for the urine or breath alcohol screen and/or urine drug screen at screening
- Has positive results at screening for human immunodeficiency virus (HIV) (Panels A \& B) or for HIV, HBsAg, or hepatitis C virus (HCV) (Panel C)
- Panels A \& B: Participants with active HCV infection or hepatitis B virus (HBV) infection. Participants with prior/inactive HCV infection or past HBV infection may be enrolled.
- Is unable to refrain from or anticipates use of any medication or substance prohibited in study
- Has taken amiodarone at any time in their life
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03295266
Start Date
December 19 2017
End Date
March 15 2018
Last Update
November 13 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Pharmacology of Miami ( Site 0001)
Hialeah, Florida, United States, 33014
2
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States, 32809