Healthy
Conditions
Brief summary
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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration | Baseline and up to approximately 24 hours | Change from Baseline in QTc following MK-8527 administration will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | Up to approximately 7 weeks | 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. |
| Number of participants who discontinue study intervention due to an AE | Up to approximately 7 weeks | 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. |
| Change from Baseline in QTc following moxifloxacin administration | Baseline and up to approximately 24 hours | Change from Baseline in QTc following moxifloxacin administration will be reported. |
| Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527 | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected at multiple time points to estimate AUC0-24 of MK-8527 |
| Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527 | At designated timepoints (up to 168 hours postdose) | Blood samples will be collected at multiple time points to estimate AUC0-168 of MK-8527 |
| Area Under the Plasma Concentration-Time curve From Time 0 to infinity (AUC0-inf) of MK-8527 | At designated timepoints (up to approximately 7 weeks) | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 |
| Maximum plasma concentration (Cmax) of MK-8527 | At designated timepoints (up to approximately 7 weeks) | Blood samples will be collected at multiple time points to estimate Cmax of MK-8527 |
| Time to maximum plasma concentration (Tmax) of MK-8527 | At designated timepoints (up to approximately 7 weeks) | Blood samples will be collected at multiple time points to estimate Tmax of MK-8527 |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed