Healthy
Conditions
Brief summary
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.
Interventions
DRUGUlonivirine
Oral tablet
DRUGMoxifloxacin
Oral tablet
DRUGUlonivirine Placebo
Oral tablet
DRUGMoxifloxacin Placebo
Oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Is in good health before randomization * Has body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
Exclusion criteria
* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Ulonivirine Administration | Baseline and up to approximately 24 hours | Change from baseline in QTc following ulonivirine administration will be reported. |
| Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc) | At designated timepoints (up to approximately 24 hours) | Blood samples will be collected to determine the Cqtc of ulonivirine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Administration | Baseline to up to approximately 24 hours | Change from baseline in QTc following moxifloxacin administration will be reported. |
| Plasma concentration of Moxifloxacin at QTc intervals (Cqtc) | At designated timepoints (up to approximately 24 hours) | Blood samples will be collected to determine the Cqtc of moxifloxacin. |
| Maximum Plasma Concentration (Cmax) of Moxifloxacin | At designated timepoints (up to approximately 168 hours) | Blood samples will be collected to determine the Cmax of moxifloxacin. |
| Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ulonivirine | At designated timepoints (up to 168 hours) | Blood samples will be collected to determine the AUC0-24 of ulonivirine. |
| Maximum Plasma Concentration (Cmax) of Ulonivirine | At designated timepoints (up to 168 hours) | Blood samples will be collected to determine the Cmax of ulonivirine. |
| Time to Maximum Plasma Concentration (Tmax) of Ulonivirine | At designated timepoints (up to 168 hours) | Blood samples will be collected to determine the Tmax of ulonivirine. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed