The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of a single dose of ulonivirine in antiretroviral therapy (ART)-naive, HIV-1 infected participants. The hypothesis tested in the study is that at a safe and well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo control, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
MK-8507 administered as a single oral dose
Change from Baseline in Plasma HIV-1 RNA
Time frame: 168 hours (7 days) postdose
Number of Participants with One or More Adverse Experiences
Time frame: Up to 21 days postdose
Area Under the Plasma Concentration-Time Curve of Ulonivirine (AUC0-168hr)
Time frame: Up to 168 hours postdose
Maximum Plasma Concentration of Ulonivirine (Cmax)
Time frame: Up to 336 hours postdose
Time of Maximum Plasma Concentration of Ulonivirine (Tmax)
Time frame: Up to 336 hours postdose
Plasma Concentration of Ulonivirine at 168 Hours Postdose (C168hr)
Time frame: 168 hours postdose
Plasma Concentration of Ulonivirine at 336 Hours Postdose (C336hr)
Time frame: 336 hours postdose
Apparent Terminal Half-Life (T1/2) of Plasma Ulonivirine
Time frame: Up to 336 hours postdose
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