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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
MK-4646 in capsular form administered orally
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002)
Chisinau, Moldova
ARENSIA Exploratory Medicine ( Site 0001)
Bucharest, Bucharest, Romania
Participants with averse events (AEs)
Percentage of participants with one or more AEs
Time frame: 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
Time frame: Up to Day 7
Viral load decline of plasma HIV-1 ribonucleic acid (RNA)
Time course of plasma HIV-1 RNA viral load decline.
Time frame: Predose, 1,2, 3, 4 and 5 days postdose
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
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose
Maximum plasma concentration (Cmax) of MK-4646
Cmax 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
Concentration at 24 hours (C24) of MK-4646
C24 postdose of plasma MK- 4646 in the fasted state
Time frame: 24 hours postdose
Time to maximum concentration (Tmax) of MK-4646
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
Half life (t1/2) of MK-4646
T1/2 postdose of plasma MK- 4646 in the fasted state
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Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose