The goal of the study is to learn what happens to MK-4482 after single and multiple doses in healthy Chinese participants over time. Researchers also want to learn about the safety of MK-4482, including how well people tolerate it.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses.
Peking University Third Hospital (Site 0001)
Beijing, Beijing Municipality, China
The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1
Cmax of N-hydroxycytidine (NHC) after a single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Single Oral Dose of MK-4482 in Period 1.
Tmax of NHC following single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
Elimination Half Life (T1/2) After Single Oral Dose of MK-4482 in Period 1
T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after a single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
Apparent Total Clearance (CL/F) After Single Oral Dose of MK-4482 in Period 1
CL/F of NHC from plasma after single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
Apparent Volume of Distribution (Vz/F) After Single Oral Dose of MK-4482 in Period 1
Vz/F of NHC during terminal phase after single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Single Oral Dose of MK-4482 in Period 1
This is a measure of the average amount of NHC in the plasma over a period of 12 hours after single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) After Single Oral Dose of MK-4482 in Period 1
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AUC0-last of NHC following a single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
Area Under The Plasma Concentration Versus Time Curve From Time Zero (pre-dose) to Extrapolated Infinite Time (AUC0-inf) After Single Oral Dose of MK-4482 in Period 1
AUC0-inf of NHC after single oral dose of MK-4482 in period 1.
Time frame: At designated time points up to 72 hours post-dose
The Maximum Observed Plasma Concentration (Cmax) After Multiple Oral Doses of MK-4482 in Period 2
Cmax of NHC after multiple oral doses of MK-4482 in period 2.
Time frame: At designated time points up to 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Multiple Oral Doses of MK-4482 in Period 2
Tmax of NHC following multiple oral doses of MK-4482 in period 2.
Time frame: At designated time points up to 72 hours post-dose
Elimination Half Life (T1/2) After Multiple Oral Doses of MK-4482 in Period 2
T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after multiple oral doses of MK-4482 in period 2.
Time frame: At designated time points up to 72 hours post-dose
Clearance at Steady State (CLss/F) After Multiple Oral Doses of MK-4482 in Period 2
CLss/F of plasma NHC following multiple doses of MK-4482 in period 2.
Time frame: At designated time points up to 72 hours post-dose
Apparent Volume of Distribution (Vz/F) After Multiple Oral Doses of MK-4482 in Period 2
Vz/F of NHC during terminal phase after multiple doses of MK-4482 in period 2.
Time frame: At designated time points up to 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Multiple Oral Doses of MK-4482 in Period 2
This is a measure of the average amount of NHC in the plasma over a period of 12 hours after multiple oral doses of MK-4482 in period 2.
Time frame: At designated time points up to 72 hours post-dose
The Minimum Concentration (Ctrough) After Multiple Oral Doses of MK-4482 in Period 2
Ctrough of NHC that occurred following multiple doses of MK-4482 in period 2.
Time frame: At designated time points up to 72 hours post-dose
Accumulation Ratio on Cmax After Multiple Oral Doses of MK-4482 in Period 2
The maximum concentration at steady state following multiple doses of MK-4482 in period 2 divided by the maximum concentration following the initial dosing in Period 1.
Time frame: At designated time points up to 72 hours post-dose
Accumulation Ratio on AUC0-12hr After Multiple Oral Doses of MK-4482
The AUC0-12hr at steady state following multiple doses of MK-4482 in period 2 divided by the AUC0-12hr following the initial dosing in Period 1.
Time frame: At designated time points up to 72 hours post-dose
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Time frame: Up to ~ 5.5 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to ~ 5.5 weeks