The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed from the plasma by hemodialysis (HD), and evaluate the safety and tolerability of MK-3402 in participants with impaired renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
MK-3402 administered as a single dose of 100 mg IV infusion on the following dosage days: Panels A to D: Day 1 Panel E: Day 1 in Periods 1 and 2
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, United States
Prism Clinical Research, LLC ( Site 0002)
Saint Paul, Minnesota, United States
Area Under the Curve From Dosing to Infinity (AUC0-inf) of MK-3402
AUC0-inf is defined as area under the plasma concentration-time curve from dosing to infinity.
Time frame: Pre-dose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Plasma Concentration at the End of Infusion (Ceoi) of MK-3402
Ceoi is defined as the amount of study drug in plasma following IV infusion administration of study drug. Plasma samples were collected at pre-specified time points and Ceoi was assessed.
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Time to Maximum Plasma Concentration (Tmax) of MK-3402
Tmax is defined as the time required for a study drug to reach maximum concentration in plasma. Plasma samples were collected at pre-specified time points and Tmax was assessed.
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Apparent Plasma Half-life (t½) of MK-3402
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak.
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Apparent Plasma Clearance (CL) of MK-3402
CL is defined as the time it takes for the study drug to be completely removed from the body's plasma.
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Volume of Distribution (Vd) of MK-3402
Vd is defined as the distributed volume of study drug in plasma.
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Participants With Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug
Time frame: Up to 15 days
Number of Participants Who Discontinued From Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug
Time frame: Up to 15 days
Dialysis Clearance Based on Plasma (CLDplasma) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate CLDplasma.
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Concentration of Dialysate (CD) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate CD.
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Amount of Drug Recovered From the Dialysate From Plasma (AED) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate AED.
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Percentage of AED (% Dose) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate AED (% dose).
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion.
Hemodialysis Clearance Based on Plasma (CLD Dialysate) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to measure CLD dialysate.
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-3402
Ae0-24 is defined as the amount of study drug unchanged in urine after 0-24 hours. Urine samples were collected at pre-specified intervals and Ae0-24 was assessed.
Time frame: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose
Fraction of Dose Recovered in Urine (Fe) of MK-3402
Fe is defined as the fraction of the dose of study drug in urine.
Time frame: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose
Renal Clearance (CLr) of MK-3402
CLr is defined as the time it takes for the study drug to be completely removed by the kidneys.
Time frame: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose