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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.
Clinical Pharmacology of Miami ( Site 0001)
Hialeah, Florida, United States
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States
Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)
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
Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)
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
Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)
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
Concentration at the End of Infusion (Ceoi) of MK-3866
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
Time to Maximum Concentration (Tmax) of MK-3866
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
Apparent Terminal Half-life (t1/2) of MK-3866
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clearance (CL) of MK-3866
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
Volume of Distribution (Vz) of MK-3866
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
Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)
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
Renal Clearance (CLr) of MK-3866
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
Number of Participants With at Least One Adverse Event (AE)
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
Number of Participants Who Discontinued the Study Due to an AE
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