HIV Infection
Conditions
Brief summary
This study will examine if at least one dose level of MK-4646 can lower HIV-1 viral load in a person's blood by a certain amount. The goals of this study are to learn about the safety of MK-4646 and if people tolerate it; and how HIV-1 viral load may decrease after starting to take MK-4646.
Interventions
DRUGMK-4646
MK-4646 in capsular form administered orally
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Other than having HIV-1, is in good health * Is antiretroviral therapy (ART)-naïve * If ART-experienced has not received any antiretroviral therapy within 60 days (or 5 half-lives, whichever is longer) prior to screening * Is willing to receive no other ART prior to Day 8 post-dose of the trial * If capable of producing sperm agrees to use contraception * If assigned female sex at birth is not breastfeeding * A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum), and uses a contraceptive method that is highly effective
Exclusion criteria
* Has acute (primary) HIV-1 infection * Has 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 * Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. * Has history of cancer (malignancy) * Has history of significant multiple and/or severe allergies * Tests positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies * Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit * Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 14 days following study intervention * Is unable to refrain from using protocol specified prohibited medications * Is an excessive smoker, or consumes excessive amounts of alcoholic or caffeinated beverages * Is a regular user of any illicit drugs or has a history of drug (including alcohol) abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants with averse events (AEs) | 14 days post last dose (Up to Day 23) | Percentage of participants with one or more AEs |
| Participants who discontinued study medication due to an AE | Up to Day 7 | Percentage of participants who discontinued study medication due to an AE |
| Viral load decline of plasma HIV-1 ribonucleic acid (RNA) | Predose, 1,2, 3, 4 and 5 days postdose | Time course of plasma HIV-1 RNA viral load decline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve from time 0 to 24 hours (AUC0-24) of MK-4646 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose | AUC0-24 postdose of plasma MK- 4646 in the fasted state |
| Maximum plasma concentration (Cmax) of MK-4646 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose | Cmax postdose of plasma MK- 4646 in the fasted state |
| Concentration at 24 hours (C24) of MK-4646 | 24 hours postdose | C24 postdose of plasma MK- 4646 in the fasted state |
| Time to maximum concentration (Tmax) of MK-4646 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose | Tmax postdose of plasma MK- 4646 in the fasted state |
| Half life (t1/2) of MK-4646 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose | T1/2 postdose of plasma MK- 4646 in the fasted state |
Countries
Moldova, Romania
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed