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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4646-003 | Other Identifier | MSD | |
| 2025-521102-17-00 | Registry Identifier | EU CT | |
| U1111-1318-7985 | Registry Identifier | UTN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4646 Panel A | Experimental | MK-4646 160 mg every 24 hours (q24h) for 7 days |
|
| MK-4646 Panel B | Experimental | MK-4646 ≤460 mg q24h for 7 days |
|
| MK-4646 Panel C | Experimental | MK-4646 ≤460 mg q24h for 7 days |
|
| MK-4646 Panel D | Experimental | MK-4646 ≤460 mg every 12 hours (q12h) for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4646 | Drug | MK-4646 in capsular form administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants with averse events (AEs) | Percentage of participants with one or more AEs | 14 days post last dose (Up to Day 23) |
| Participants who discontinued study medication due to an AE | Percentage of participants who discontinued study medication due to an AE | Up to Day 7 |
| Viral load decline of plasma HIV-1 ribonucleic acid (RNA) | Time course of plasma HIV-1 RNA viral load decline. | Predose, 1,2, 3, 4 and 5 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time 0 to 24 hours (AUC0-24) of MK-4646 | AUC0-24 postdose of plasma MK- 4646 in the fasted state | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose |
| Maximum plasma concentration (Cmax) of MK-4646 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002) | Chisinau | 2025 | Moldova | |||
| ARENSIA Exploratory Medicine ( Site 0001) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Cmax postdose of plasma MK- 4646 in the fasted state
| Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose |
| Concentration at 24 hours (C24) of MK-4646 | C24 postdose of plasma MK- 4646 in the fasted state | 24 hours postdose |
| Time to maximum concentration (Tmax) of MK-4646 | Tmax postdose of plasma MK- 4646 in the fasted state | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose |
| Half life (t1/2) of MK-4646 | T1/2 postdose of plasma MK- 4646 in the fasted state | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose |
| Bucharest |
| Bucharest |
| 021105 |
| Romania |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |