MK-4646
DrugMK-4646 in capsular form administered orally
NCT Number: NCT07042945
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002), Chisinau, Moldova
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MK-4646 in capsular form administered orally
Time frame: 14 days post last dose (Up to Day 23)
Percentage of participants with one or more AEs
Time frame: Up to Day 7
Percentage of participants who discontinued study medication due to an AE
Time frame: Predose, 1,2, 3, 4 and 5 days postdose
Time course of plasma HIV-1 RNA viral load decline.
Time frame: 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
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose
Cmax postdose of plasma MK- 4646 in the fasted state
Time frame: 24 hours postdose
C24 postdose of plasma MK- 4646 in the fasted state
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose
Tmax postdose of plasma MK- 4646 in the fasted state
Time frame: 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
Merck Sharp & Dohme LLC
Industry
Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of MK-4646 Monotherapy in Antiretroviral Therapy-Naïve Participants With HIV-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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