Researchers are looking for new treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Ulonivirine (MK-8507) is a study medicine designed to treat HIV-1 The goal of this study is to learn if ulonivirine does not increase the QT interval (a measure of heart rhythm on an electrocardiogram) above a certain amount. Researchers also want to learn what happens to the amount of ulonivirine in a healthy person's body over time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Oral tablet
Oral tablet
Oral tablet
Oral tablet
ICON Early Phase Services (0001)
San Antonio, Texas, United States
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Ulonivirine Administration
Change from baseline in QTc following ulonivirine administration will be reported.
Time frame: Baseline and up to approximately 24 hours
Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc)
Blood samples will be collected to determine the Cqtc of ulonivirine.
Time frame: At designated timepoints (up to approximately 24 hours)
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Administration
Change from baseline in QTc following moxifloxacin administration will be reported.
Time frame: Baseline to up to approximately 24 hours
Plasma concentration of Moxifloxacin at QTc intervals (Cqtc)
Blood samples will be collected to determine the Cqtc of moxifloxacin.
Time frame: At designated timepoints (up to approximately 24 hours)
Maximum Plasma Concentration (Cmax) of Moxifloxacin
Blood samples will be collected to determine the Cmax of moxifloxacin.
Time frame: At designated timepoints (up to approximately 168 hours)
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ulonivirine
Blood samples will be collected to determine the AUC0-24 of ulonivirine.
Time frame: At designated timepoints (up to 168 hours)
Maximum Plasma Concentration (Cmax) of Ulonivirine
Blood samples will be collected to determine the Cmax of ulonivirine.
Time frame: At designated timepoints (up to 168 hours)
Time to Maximum Plasma Concentration (Tmax) of Ulonivirine
Blood samples will be collected to determine the Tmax of ulonivirine.
Time frame: At designated timepoints (up to 168 hours)
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