Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often. MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet. The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Oral administration
Oral administration
Oral administration
Hassman Research Institute Marlton Site ( Site 0001)
Marlton, New Jersey, United States
Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration
Change from Baseline in QTc following MK-8527 administration will be reported.
Time frame: Baseline and up to approximately 24 hours
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
Time frame: Up to approximately 7 weeks
Number of participants who discontinue study intervention due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately 7 weeks
Change from Baseline in QTc following moxifloxacin administration
Change from Baseline in QTc following moxifloxacin administration will be reported.
Time frame: Baseline and up to approximately 24 hours
Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527
Blood samples will be collected at multiple time points to estimate AUC0-24 of MK-8527
Time frame: At designated timepoints (up to 24 hours postdose)
Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527
Blood samples will be collected at multiple time points to estimate AUC0-168 of MK-8527
Time frame: At designated timepoints (up to 168 hours postdose)
Area Under the Plasma Concentration-Time curve From Time 0 to infinity (AUC0-inf) of MK-8527
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527
Time frame: At designated timepoints (up to approximately 7 weeks)
Maximum plasma concentration (Cmax) of MK-8527
Blood samples will be collected at multiple time points to estimate Cmax of MK-8527
Time frame: At designated timepoints (up to approximately 7 weeks)
Time to maximum plasma concentration (Tmax) of MK-8527
Blood samples will be collected at multiple time points to estimate Tmax of MK-8527
Time frame: At designated timepoints (up to approximately 7 weeks)
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