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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03295266
• Collaborator: (none)
• Enrollment: 9
• Locations: 2
• Arms: 3
• Actual Duration (Months): 2.8
• Patients Per Site: 4.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency; Antibacterial Agents	Drug: MK-3866	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-3866 When Administered to Subjects With Moderate and Severe Hepatic Impairment
• Actual Study Start Date: Dec 19, 2017
• Actual Primary Completion Date: Mar 15, 2018
• Actual Study Completion Date: Mar 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate Hepatic Impairment (Panel A) Participants with moderate HI (estimated glomerular filtration rate [eGFR] of ≤60mL/min/1.73m^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.	Drug: MK-3866; Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.
Experimental: Severe Hepatic Impairment (Panel B) Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.	Drug: MK-3866; Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.
Experimental: Healthy Matched Controls (Panel C) Healthy participants receive a single IV dose of MK-3866 (150 mg) on Day 1.	Drug: MK-3866; Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.

Outcome Measures

Primary Outcome Measures

1. Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞) [Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose]

   AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.

2. Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last) [Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose]

   AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.

3. Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr) [Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose]

   AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.

4. Concentration at the End of Infusion (Ceoi) of MK-3866 [0.5 (end of infusion) hours postdose]

   The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.

5. Time to Maximum Concentration (Tmax) of MK-3866 [Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose]

   Tmax is the time at which the maximum plasma drug concentration is detected.

6. Apparent Terminal Half-life (t1/2) of MK-3866 [Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose]

   Apparent t1/2 is the elimination half-life of MK-3866 from plasma.

7. Clearance (CL) of MK-3866 [Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose]

   CL is the volume of plasma from which the study drug is completely removed per unit time.

8. Volume of Distribution (Vz) of MK-3866 [Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose]

   Vz is the apparent volume of distribution during the terminal phase.

Secondary Outcome Measures

1. Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe) [Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose]

   Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.

2. Renal Clearance (CLr) of MK-3866 [Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose]

   CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.

3. Number of Participants With at Least One Adverse Event (AE) [Up to 14 days]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

4. Number of Participants Who Discontinued the Study Due to an AE [Up to 14 days]

   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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)

• 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 &

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami ( Site 0001)	Hialeah	Florida	United States	33014
2	Orlando Clinical Research Center ( Site 0002)	Orlando	Florida	United States	32809

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 6, 2017

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT03295266
• Other Study ID Numbers: 3866-006; MK-3866-006
• First Posted: Sep 27, 2017
• Last Update Posted: Nov 13, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure

Study Results

Participant Flow

Recruitment Details	The study terminated prior to enrollment of any healthy control participants.
Pre-assignment Detail	Participants with moderate or severe hepatic impairment (HI) based on estimated glomerular filtration rate (eGFR) were enrolled at 2 study centers in the US.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Period Title: Overall Study
STARTED	5	4
COMPLETED	5	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)	Total
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Total of all reporting groups
Overall Participants	5	4	9
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.0 (5.96)	56.0 (8.98)	58.2 (7.24)
Sex: Female, Male (Count of Participants)
Female	1 20%	1 25%	2 22.2%
Male	4 80%	3 75%	7 77.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 40%	2 50%	4 44.4%
Not Hispanic or Latino	3 60%	2 50%	5 55.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 25%	1 11.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 20%	0 0%	1 11.1%
White	4 80%	3 75%	7 77.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)
Description	AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.
Time Frame	Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Geometric Mean (Geometric Coefficient of Variation) [hour*µM]	71.4 (7.3)	58.6 (41.4)

2. Primary Outcome

Title	Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)
Description	AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.
Time Frame	Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Geometric Mean (Geometric Coefficient of Variation) [hour*µM]	70.7 (7.4)	57.9 (42.2)

3. Primary Outcome

Title	Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)
Description	AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.
Time Frame	Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	3
Geometric Mean (Geometric Coefficient of Variation) [hour*µM]	67.6 (7.5)	54.6 (34.5)

4. Primary Outcome

Title	Concentration at the End of Infusion (Ceoi) of MK-3866
Description	The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.
Time Frame	0.5 (end of infusion) hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Geometric Mean (Geometric Coefficient of Variation) [µM]	19.2 (22.0)	11.0 (30.4)

5. Primary Outcome

Title	Time to Maximum Concentration (Tmax) of MK-3866
Description	Tmax is the time at which the maximum plasma drug concentration is detected.
Time Frame	Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Median (Full Range) [hours]	0.47	0.50

6. Primary Outcome

Title	Apparent Terminal Half-life (t1/2) of MK-3866
Description	Apparent t1/2 is the elimination half-life of MK-3866 from plasma.
Time Frame	Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Geometric Mean (Geometric Coefficient of Variation) [hours]	6.54 (13.3)	6.02 (4.16)

7. Primary Outcome

Title	Clearance (CL) of MK-3866
Description	CL is the volume of plasma from which the study drug is completely removed per unit time.
Time Frame	Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Geometric Mean (Geometric Coefficient of Variation) [Liters/hour]	4.16 (7.3)	5.07 (41.3)

8. Primary Outcome

Title	Volume of Distribution (Vz) of MK-3866
Description	Vz is the apparent volume of distribution during the terminal phase.
Time Frame	Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants with data available are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Geometric Mean (Geometric Coefficient of Variation) [Liters]	39.3 (15.8)	44.0 (27.4)

9. Secondary Outcome

Title	Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)
Description	Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
Time Frame	Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose

Outcome Measure Data

Analysis Population Description

Urine samples were collected but were not analyzed.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	0	0

10. Secondary Outcome

Title	Renal Clearance (CLr) of MK-3866
Description	CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
Time Frame	Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose

Outcome Measure Data

Analysis Population Description

Urine samples were collected but were not analyzed.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	0	0

11. Secondary Outcome

Title	Number of Participants With at Least One Adverse Event (AE)
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame	Up to 14 days

Outcome Measure Data

Analysis Population Description

All treated participants are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Number [Participants]	2 40%	1 25%

12. Secondary Outcome

Title	Number of Participants Who Discontinued the Study Due to an AE
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame	Up to 14 days

Outcome Measure Data

Analysis Population Description

All treated participants are included.

Arm/Group Title	Moderate Hepatic Impairment (Panel A)	Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.	Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
Measure Participants	5	4
Number [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Up to 14 days
Adverse Event Reporting Description	All treated participants are included.
Arm/Group Title	Moderate Hepatic Impairment (Panel A)		Severe Hepatic Impairment (Panel B)
Arm/Group Description	Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.		Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.
All Cause Mortality
	Moderate Hepatic Impairment (Panel A)		Severe Hepatic Impairment (Panel B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)
Serious Adverse Events
	Moderate Hepatic Impairment (Panel A)		Severe Hepatic Impairment (Panel B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Moderate Hepatic Impairment (Panel A)		Severe Hepatic Impairment (Panel B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/5 (40%)		1/4 (25%)
Gastrointestinal disorders
Abdominal pain	1/5 (20%)	1	0/4 (0%)	0
Diarrhoea	1/5 (20%)	1	0/4 (0%)	0
Injury, poisoning and procedural complications
Skin abrasion	0/5 (0%)	0	1/4 (25%)	1
Nervous system disorders
Dysgeusia	1/5 (20%)	1	0/4 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.