The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.
Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
The plasma HIV-RNA will be measured based on a longitudinal data analysis model containing fixed effects for dose level, and dose level by time interaction, and a random effect of MK-8510 (prodrug). The change from baseline for each dose level at 168-hours post baseline will be estimated from this model.
Time frame: Baseline and 168 hours post-dose
Percentage of Participants Who Experience an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 36 days
Percentage of Participants Who Discontinued from Study Due to an Adverse Event (AE)
The percentage of participants who discontinue study due to an AE will be presented.
Time frame: Up to 36 days
Area Under the Concentration-Time Curve of MK-8558 From Time 0 to 168 Hours (AUC0-168 hr)
The AUC0-168 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168 hours post-dose.
Time frame: At protocol specific timepoints up to 168 hours post-dose
Area Under the Concentration-Time Curve of MK-8558 From Time 0 to last (AUC0-last)
AUC0-last of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Time frame: At protocol specific time points up to 504 hours post-dose
Concentration at 168 Hours Post-dose (C168) of MK-8558
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
C168hr of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated.
Time frame: 168 hours post-dose
Maximum Concentration (Cmax) of MK-8558
Cmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Time frame: At protocol specific time points up to 504 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of MK-8558
Tmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Time frame: At protocol specific time points up to 504 hours post-dose
Half Life (t1/2) of MK-8558
t1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Time frame: At protocol specific time points up to 504 hours post-dose
Apparent Plasma Clearance of Drug After Extravascular Administration (CL/F) of MK-8558
CL/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Time frame: At protocol specific time points up to 504 hours post-dose
Apparent Volume of Distribution in the Terminal State After Extravascular Administration (Vz/F) of MK-8558
Vz/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Time frame: At protocol specific time points up to 504 hours post-dose
Terminal t1/2 of MK-8558
Terminal t1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.
Time frame: At protocol specific time points up to 504 hours post-dose