A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT07063238
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 42
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
The main exclusion criteria include but are not limited to the following:
- Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- Has history of cancer (malignancy).
- Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MK-8527 PLUS Moxifloxacin and Placebo MK-8527 Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization. Moxifloxacin PLUS MK-8527 and Placebo Moxifloxacin Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization. MK-8527 PLUS Moxifloxacin and Placebo Moxifloxacin Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization. MK-8527 PLUS Moxifloxacin and Placebo Placebo Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization. Moxifloxacin PLUS MK-8527 and Placebo MK-8527 Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization. Moxifloxacin PLUS MK-8527 and Placebo Placebo Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization. Placebo PLUS MK-8527 and Moxifloxacin Placebo Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization. Placebo PLUS MK-8527 and Moxifloxacin MK-8527 Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization. Placebo PLUS MK-8527 and Moxifloxacin Moxifloxacin Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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
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